Evaluation of Automatic Class III Designation (De Novo) Summaries
The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De Novo classification option as an alternate pathway to classify novel medical devices that had automatically been placed in Class III after receiving a "not substantially equivalent" (NSE) determination in response to a premarket notification [510(k)] submission. Section 513(f)(2) of the FD&C Act was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA), on July 9, 2012, to allow a sponsor to submit a De Novo classification request to the FDA for without first being required to submit a 510(k).
There are two options for De Novo classification for novel devices of low to moderate risk.
- Option 1: Any person who receives an NSE determination in response to a 510(k) submission may, within 30 days of receipt of the NSE determination, submit a De Novo request for the FDA to make a risk-based evaluation for classification of the device into Class I or II.
- Option 2: Any person who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may submit a De Novo request for the FDA to make a risk-based classification of the device into Class I or II, without first submitting a 510(k) and receiving an NSE determination.
Devices that are classified through the de novo process may be marketed and used as predicates for future 510(k) submissions.
Since 2010, the FDA has begun releasing summary documents for devices classified through the De Novo process. The De Novo summary is intended to present an objective and balanced summary of the scientific evidence that served as the basis for the decision to grant a De Novo request. The De Novo summary also serves as a resource regarding the types of information necessary to support substantial equivalence for device manufacturers that may wish to use the device as a predicate for future 510(k) submissions.
Links to all available De Novo summary documents can be found in the table below.
| Device Name | DEN# | Classification Order | Decision Summary |
|---|---|---|---|
| Cue COVID-19 Molecular Test | DEN220028 | Classification Order | |
| Tristel Duo ULT | DEN220041 | Classification Order | |
| B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System | DEN220027 | Classification Order | |
| Stanza | DEN220083 | Classification Order | |
| VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator |
DEN210038 | Classification Order | |
| VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator |
DEN210040 | Classification Order | |
| N-SWEAT Patch | DEN210055 | Classification Order | |
| MISHA™ Knee System | DEN220033 | Classification Order | |
| NTX100 Tonic Motor Activation (NTX100 ToMAc) System | DEN220059 | Classification Order | |
| Bateman™ Bottle | DEN220082 | Classification Order | |
| Masimo SafetyNet Opioid System | DEN200011 | Classification Order | |
| RemeOsTM Screw LAG Solid | DEN220030 | Classification Order | |
| SNOO Smart Sleeper | DEN210039 | Classification Order | |
| Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set | DEN220039 | Classification Order | Decision Summary |
| Lenire | DEN210033 | Classification Order | |
| Caption Interpretation Automated Ejection Fraction Software | DEN220063 | Classification Order | |
| Pill Sense System | DEN220065 | Classification Order | |
| PMD-200 | DEN210022 | Classification Order | |
| Active Anthrax Detect Plus Rapid Test | DEN220044 | Classification Order | |
| RefleXion Medical Radiotherapy System (RMRS) | DEN220014 | Classification Order | |
| BioXmark | DEN220017 | Classification Order | |
| Tornier Pyrocarbon Humeral Head | DEN220012 | Classification Order | |
| BrainTemp Neonate (BTNeo) System | DEN200042 | Classification Order | Decision Summary |
| Eonis™ SCID-SMA Kit | DEN200044 | Classification Order | |
| ScanNav Anatomy Peripheral Nerve Block | DEN220024 | Classification Order | |
| The Cooral System | DEN210027 | Classification Order | |
| Phagenyx System | DEN220025 | Classification Order | |
| Vibrant System | DEN210052 | Classification Order | |
| AccuMeasure™ System | DEN210032 | Classification Order | Decision Summary |
| APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System |
DEN210045 | Classification Order | Decision Summary |
| Zuno Smart Sterilization Container | DEN210004 | Classification Order | |
| ProdiGI | DEN220006 | Classification Order | |
| Parsortix® PC1 Device | DEN200062 | Classification Order | |
| Quell-FM | DEN210046 | Classification Order | Decision Summary |
| CERAMENT G | DEN210044 | Classification Order | |
| Lumipulse G β-Amyloid Ratio (1-42/1-40) | DEN200072 | Classification Order | Decision Summary |
| Kerasave | DEN200063 | Classification Order | Decision Summary |
| BioFire Joint Infection (JI) Panel | DEN200066 | Classification Order | Decision Summary |
| ONE Male Condom | DEN210034 | Classification Order | Decision Summary |
| CavaClear Laser Sheath | DEN210024 | Classification Order | Decision Summary |
| POMC/PCSK1/LEPR CDx Panel | DEN200059 | Classification Order | Decision Summary |
| Sunrise Sleep Disorder Diagnostic Aid | DEN210015 | Classification Order | |
| Comfort Marker 2.0. | DEN200041 | Classification Order | Decision Summary |
| Klox Biophotonic LumiHeal System | DEN200005 | Classification Order | Decision Summary |
| vPatch | DEN210012 | Classification Order | |
| EaseVRx | DEN210014 | Classification Order | Decision Summary |
| Hemolung Respiratory Assist System | DEN210006 | Classification Order | Decision Summary |
| OMNIgene•GUT Dx | DEN200040 | Classification Order | |
| MyCare Psychiatry Clozapine Assay Kit, Saladax Biomedical, Inc. | DEN190028 | Classification Order | Decision Summary |
| Luminopia One | DEN210005 | Classification Order | Decision Summary |
| iotaSOFT Insertion System - Drive Unit, Controller and Accessories | DEN190055 | Classification Order | Decision Summary |
| Paige Prostate | DEN200080 | Classification Order | Decision Summary |
| FEops HEARTguide | DEN200030 | Classification Order | Decision Summary |
| OsteoProbe | DEN210013 | Classification Order | Decision Summary |
| SureTune4 Software | DEN210003 | Classification Order | Decision Summary |
| Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System | DEN200064 | Classification Order | Decision Summary |
| ADVIA Centaur Enhanced Liver Fibrosis (ELF) | DEN190056 | Classification Order | Decision Summary |
| InSpace™ Subacromial Tissue Spacer System | DEN200039 | Classification Order | Decision Summary |
| Portable Neuromodulation Stimulator (PoNS) | DEN200050 | Classification Order | |
| Cognoa ASD Diagnosis Aid | DEN200069 | Classification Order | Decision Summary |
| SafeBreak® Vascular | DEN190043 | Classification Order | Decision Summary |
| Oxehealth Vital Signs | DEN200019 | Classification Order | Decision Summary |
| Neurolutions IpsiHand Upper Extremity Rehabilitation System | DEN200046 | Classification Order | Decision Summary |
| GI Genius | DEN200055 | Classification Order | Decision Summary |
| Gili Pro BioSensor | DEN200038 | Classification Order | Decision Summary |
| ClearUP Sinus Relief | DEN200006 | Classification Order | Decision Summary |
| Analytic for Hemodynamic Instability (AHI) | DEN200022 | Classification Order | |
| Hominis Surgical System | DEN190022 | Classification Order | Decision Summary |
| Q-Collar | DEN200017 | Classification Order | Decision Summary |
| Lumenis Stellar M22 | DEN200028 | Classification Order | |
| eXciteOSA without remote control, eXciteOSA with remote control | DEN200018 | Classification Order | Decision Summary |
| EndoRotor | DEN200016 | Classification Order | Decision Summary |
| Helix Laboratory Platform | DEN190035 | Classification Order | |
| BEAR® (Bridge-Enhanced ACL Repair) Implant | DEN200035 | Classification Order | Decision Summary |
| Parallel | DEN200029 | Classification Order | |
| CADScor System | DEN190047 | Classification Order | Decision Summary |
| FilmArray Global Fever Panel | DEN200043 | Classification Order | |
| Acumen Assisted Fluid Management (AFM) Software Feature | DEN190029 | Classification Order | Decision Summary |
| NightWare Kit (Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable) | DEN200033 | Classification Order | Decision Summary |
| Theranova Dialyzers (Theranova 400, Theranova 500) | DEN190042 | Classification Order | Decision Summary |
| Cell-Free DNA BCT | DEN200001 | Classification Order | Decision Summary |
| cobas EBV | DEN200015 | Classification Order | Decision Summary |
| EndeavorRx | DEN200026 | Classification Order | Decision Summary |
| NP Screen | DEN190031 | Classification Order | Decision Summary |
| CARPEDIEM System | DEN180055 | Classification Order | |
| OGmend® Implant System | DEN180065 | Classification Order | Decision Summary |
| iTEAR100 Neurostimulator | DEN190026 | Classification Order | Decision Summary |
| OraQuick Ebola Rapid Antigen Test | DEN190025 | Classification Order | Decision Summary |
| QMS Plazomicin Immunoassay | DEN180030 | Classification Order | Decision Summary |
| iTind System | DEN190020 | Classification Order | Decision Summary |
| AmplideX Fragile X Dx & Carrier Screen Kit | DEN190023 | Classification Order | Decision Summary |
| Caption Guidance | DEN190040 | Classification Order | Decision Summary |
| The Quantra QPlus System | DEN180017 | Classification Order | Decision Summary |
| Control-IQ Technology | DEN190034 | Classification Order | Decision Summary |
| Surfacer Inside-Out Access Catheter System | DEN190038 | Classification Order | |
| GSP Neonatal Creatine Kinase - MM kit | DEN180056 | Classification Order | Decision Summary |
| EchoTip® Insight™ Portosystemic Pressure Gradient Measuring System | DEN180062 | Classification Order | Decision Summary |
| t:Slim X2 insulin pump with interoperable technology | DEN180058 | Classification Order | Decision Summary |
| WOUNDCHEK Bacterial Status | DEN180014 | Classification Order | Decision Summary |
| ContaCT | DEN170073 | Classification Order | Decision Summary |
| QuantX | DEN170022 | Classification Order | Decision Summary |
| Mucosal Integrity Conductivity (MI) Test System | DEN180067 | Classification Order | Decision Summary |
| cobas vivoDx MRSA | DEN190016 | Classification Order | Decision Summary |
| IB-Stim | DEN180057 | Classification Order | Decision Summary |
| STUDIO on the Cloud Data Management Software | DEN140016 | Classification Order | Decision Summary |
| Plenity | DEN180060 | Classification Order | Decision Summary |
| Nerivio Migra | DEN180059 | Classification Order | Decision Summary |
| Monarch eTNS System | DEN180041 | Classification Order | Decision Summary |
| Bose Hearing Aid | DEN180026 | Classification Order | Decision Summary |
| PREVENA 125 and PREVENA PLUS 125 Therapy Units | DEN180013 | Classification Order | Decision Summary |
| Aptima Mycoplasma genitalium Assay | DEN180047 | Classification Order | Decision Summary |
| Synovasure Alpha Defensin Lateral Flow Test Kit Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test) Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test) Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test) Synovasure Alpha Defensin Control Kit |
DEN180032 | Classification Order | Decision Summary |
| ClearMate | DEN170044 | Classification Order | Decision Summary |
| Comaneci Embolization Assist Device | DEN170064 | Classification Order | Decision Summary |
| Early Bird Bleed Monitoring System | DEN180021 | Classification Order | Decision Summary |
| Leica FL400 | DEN180024 | Classification Order | Decision Summary |
| LOADPRO™ Intraoperative Rod Strain Sensor | DEN180012 | Classification Order | Decision Summary |
| ZIKV Detect 2.0 IgM Capture ELISA | DEN180069 | Classification Order | Decision Summary |
| 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | DEN180028 | Classification Order | Decision Summary |
| 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) | DEN170046 | Classification Order | Decision Summary |
| Irregular Rhythm Notification Feature | DEN180042 | Classification Order | Decision Summary |
| ECG App | DEN180044 | Classification Order | Decision Summary |
| EyeBOX | DEN170091 | Classification Order | Decision Summary |
| SEM Scanner | DEN170021 | Classification Order | Decision Summary |
| Innovo | DEN170049 | Classification Order | Decision Summary |
| Medtronic DUET™ External Drainage and Monitoring System (EDMS) | DEN120017 | Classification Order | Decision Summary |
| Percutaneous Surgical Set with 5 mm or 10 mm Attachments | DEN110016 | Classification Order | Decision Summary |
| ViruLite Cold Sore Machine | DEN090012 | Classification Order | Decision Summary |
| picoAMH ELISA | DEN180004 | Classification Order | Decision Summary |
| Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System | DEN170092 | Classification Order | Decision Summary |
| Alethia CMV Assay Test System | DEN180040 | Classification Order | Decision Summary |
| Retrograde Intubation Set | DEN170055 | Classification Order | Decision Summary |
| ENLIGHT 1810 | DEN170072 | Classification Order | Decision Summary |
| MLL (KMT2A) Breakapart FISH Probe Kit P53 (TP53) Deletion FISH Probe Kit Del(20q) Deletion FISH Probe Kit CBFβ (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit Del(5q) Deletion FISH Probe Kit Del(7q) Deletion FISH Probe Kit AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion FISH Probe Kit EVI1 (MECOM) Breakapart FISH Probe Kit |
DEN170070 | Classification Order | Decision Summary |
| Miris Human Milk Analyzer | DEN180007 | Classification Order | Decision Summary |
| Dexcom G6 Continuous Glucose Monitoring System | DEN170088 | Classification Order | Decision Summary |
| BONEBRIDGE | DEN170009 | Classification Order | Decision Summary |
| MALDI Biotyper CA System | DEN170081 | Classification Order | Decision Summary |
| Hemospray® Endoscopic Hemostat | DEN170015 | Classification Order | Decision Summary |
| Parathyroid Detection (Model PTeye) System | DEN170056 | Classification Order | Decision Summary |
| Adaptive Biotechnologies clonoSEQ Assay | DEN170080 | Classification Order | Decision Summary |
| Precision Flow® HVNI | DEN170001 | Classification Order | Decision Summary |
| Acumen Hypotension Prediction Index (HPI) Feature Software | DEN160044 | Classification Order | Decision Summary |
| Ellipsys Vascular Access System | DEN170004 | Classification Order | Decision Summary |
| everlinQ endoAVF System | DEN160006 | Classification Order | Decision Summary |
| CURVE™ Positive Airway Pressure System | DEN170089 | Classification Order | Decision Summary |
| SkinPen Precision System | DEN160029 | Classification Order | Decision Summary |
| dermPACE System | DEN160037 | Classification Order | Decision Summary |
| PrimeStore MTM | DEN170029 | Classification Order | Decision Summary |
| GeneSTAT.MDx Coccidioides Assay | DEN170041 | Classification Order | Decision Summary |
| DreaMed Advisor Pro | DEN170043 | Classification Order | Decision Summary |
| OsteoDetect | DEN180005 | Classification Order | Decision Summary |
| MolecuLight i:X | DEN180008 | Classification Order | Decision Summary |
| TrueTear Intranasal Tear Neurostimulator | DEN170086 | Classification Order | Decision Summary |
| Unyvero LRT Application | DEN170047 | Classification Order | Decision Summary |
| Brainsway Deep Transcranial Magnetic Stimulation System | DEN170078 | Classification Order | Decision Summary |
| MATRx plus | DEN170090 | Classification Order | Decision Summary |
| IDx-DR | DEN180001 | Classification Order | Decision Summary |
| Cala ONE | DEN170028 | Classification Order | Decision Summary |
| ThermoNeuroModulation (TNM) Device | DEN170023 | Classification Order | Decision Summary |
| LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay | DEN170010 | Classification Order | Decision Summary |
| Natural Cycles | DEN170052 | Classification Order | Decision Summary |
| IlluminOss Photodynamic Bone Stabilization System | DEN160062 | Classification Order | Decision Summary |
| AQUABEAM System | DEN170024 | Classification Order | Decision Summary |
| remOVE System | DEN160014 | Classification Order | Decision Summary |
| NSS-2 BRIDGE | DEN170018 | Classification Order | Decision Summary |
| CipherOx CRI™ Tablet | DEN160020 | Classification Order | Decision Summary |
| Banyan BTI | DEN170045 | Classification Order | Decision Summary |
| FilmArray Respiratory Panel 2 plus (RP2plus) | DEN170017 | Classification Order | Decision Summary |
| ContainOR | DEN170075 | Classification Order | Decision Summary |
| Ventana MMR IHC Panel | DEN170030 | Classification Order | Decision Summary |
| ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit | DEN160025 | Classification Order | Decision Summary |
| reSET | DEN160018 | Classification Order | Decision Summary |
| Fetal Pillow | DEN150053 | Classification Order | Decision Summary |
| ClearLLab Reagents (T1, T2, B1, B2, M) | DEN160047 | Classification Order | Decision Summary |
| D2 Dressing | DEN160012 | Classification Order | |
| gammaCore Non-invasive Vagus Nerve Stimulator | DEN150048 | Classification Order | Decision Summary |
| MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) | DEN170058 | Classification Order | Decision Summary |
| 23andMe Personal Genome Service (PGS) Test | DEN160026 | Classification Order | Decision Summary |
| Philips IntelliSite Pathology Solution (PIPS) | DEN160056 | Classification Order | Decision Summary |
| MiSeqDx Universal Kit 1.0 | DEN130042 | Classification Order | Decision Summary |
| Quantitation of Organophosphate Metabolites in Urine by LC/MS/MS | DEN130005 | Classification Order | Decision Summary |
| ARK Voriconazole II Assay Test System | DEN160033 | Classification Order | Decision Summary |
| Embosphere Microspheres | DEN160040 | Classification Order | Decision Summary |
| Sentinel® Cerebral Protection System | DEN160043 | Classification Order | Decision Summary |
| Vitamin D 200M Assay for the Topaz System | DEN170019 | Classification Order | Decision Summary |
| AeroForm® Tissue Expander System | DEN150055 | Classification Order | Decision Summary |
| Intranasal Tear Neurostimulator | DEN160030 | Classification Order | Decision Summary |
| ipsogen® JAK2 RGQ PCR Kit | DEN160028 | Classification Order | Decision Summary |
| Accelerate PhenoTest BC Kit | DEN160032 | Classification Order | Decision Summary |
| Brain Sentinel Monitoring and Alerting System | DEN140033 | Classification Order | Decision Summary |
| CINtec Histology | DEN160019 | Classification Order | Decision Summary |
| Illumina MiSeqDx Platform | DEN130011 | Classification Order | Decision Summary |
| Dexcom Share Direct Secondary Displays | DEN140038 | Classification Order | Decision Summary |
| SEEKER System | DEN150035 | Classification Order | Decision Summary |
| Levita Magnetic Surgical System | DEN150007 | Classification Order | Decision Summary |
| CleanCision™ Wound Retraction and Protection System | DEN150038 | Classification Order | Decision Summary |
| Elecsys AMH System | DEN150057 | Classification Order | Decision Summary |
| SENSIMED Triggerfish® | DEN140017 | Classification Order | Decision Summary |
| cNEP Airway Management System | DEN140024 | Classification Order | Decision Summary |
| Sensor Monitored Alimentary Restriction Therapy (SMART) Device | DEN150033 | Classification Order | Decision Summary |
| Hem-Avert Perianal Stabilizer | DEN160005 | Classification Order | Decision Summary |
| Ultravision™ Visual Field Clearing System | DEN150022 | Classification Order | Decision Summary |
| ACCLARENT AERA™ Eustachian Tube Balloon Dilation System | DEN150056 | Classification Order | Decision Summary |
| Tear Duct Occluder | DEN140022 | Classification Order | Decision Summary |
| Vioguard Self-Sanitizing Keyboard (Model UVKB50) | DEN100013 | Classification Order | Decision Summary |
| BD MAX Vaginal Panel | DEN160001 | Classification Order | Decision Summary |
| APAS Compact | DEN150059 | Classification Order | Decision Summary |
| BrainPulse, Model 1100 | DEN140040 | Classification Order | Decision Summary |
| Symphony Device (Models 09-0002-01, 09-0003-01, and 09-0004-01) | DEN110011 | Classification Order | Decision Summary |
| Trevo ProVue and XP ProVue Retrievers | DEN150049 | Classification Order | Decision Summary |
| ImPACT and ImPACT Pediatric | DEN150037 | Classification Order | Decision Summary |
| Permaseal | DEN150029 | Classification Order | Decision Summary |
| KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay | DEN150030 | Classification Order | Decision Summary |
| QuantideX qPCR BCR-ABL IS Kit | DEN160003 | Classification Order | Decision Summary |
| EPIC ClearViewTM System | DEN150004 | Classification Order | Decision Summary |
| Pediatric Vision Scanner | DEN130051 | Classification Order | Decision Summary |
| WallFlex Biliary RX Fully Covered Stent System RMV | DEN150040 | Classification Order | Decision Summary |
| Cerêve Sleep System | DEN140032 | Classification Order | Decision Summary |
| B·R·A·H·M·S PCT sensitive KRYPTOR® | DEN150009 | Classification Order | Decision Summary |
| Esophageal Cooling Device | DEN140018 | Classification Order | Decision Summary |
| PneumoLiner | DEN150028 | Classification Order | Decision Summary |
| Amplichek II | DEN150058 | Classification Order | Decision Summary |
| RELIZORB™ | DEN150001 | Classification Order | Decision Summary |
| Sonablate® 450 | DEN150011 | Classification Order | Decision Summary |
| EarLens™ Contact Hearing Device | DEN150002 | Classification Order | Decision Summary |
| Newa™ | DEN150005 | Classification Order | Decision Summary |
| INVOcell™ Intravaginal Culture System | DEN150008 | Classification Order | Decision Summary |
| FilmArray® Meningitis/Encephalitis (ME) Panel | DEN150013 | Classification Order | Decision Summary |
| BrainScope Ahead 100, Models CV-100 and M-100 | DEN140025 | Classification Order | Decision Summary |
| EnLite™ Neonatal TREC Kit | DEN140010 | Classification Order | Decision Summary |
| DigniCap™ Scalp Cooling System | DEN150010 | Classification Order | Decision Summary |
| Eclipse System | DEN140020 | Classification Order | Decision Summary |
| NOVA View® Automated Fluorescence Microscope | DEN140039 | Classification Order | Decision Summary |
| 23andMe Personal Genome Service (PGS) Carrier Screening Test for Bloom Syndrome | DEN140044 | Classification Order | Decision Summary |
| Amigo® Remote Catheter System (Amigo RCS) | DEN140009 | Classification Order | Decision Summary |
| Prostate Mechanical Imager (PMI) | DEN100016 | Classification Order | Decision Summary |
| Cognivue | DEN130033 | Classification Order | Decision Summary |
| Zanza-Click, Mini-Click, Disc-o-Click | DEN130019 | Classification Order | Decision Summary |
| Reza Band® Upper Esophageal Sphincter (UES) Assist Device | DEN130046 | Classification Order | Decision Summary |
| SpaceOAR System | DEN140030 | Classification Order | Decision Summary |
| VasoPrep Surgical Marking Pen | DEN130004 | Classification Order | Decision Summary |
| Zap-It! | DEN100024 | Classification Order | Decision Summary |
| HeartFlow FFRCT v.1.4 | DEN130045 | Classification Order | Decision Summary |
| Eeva® System | DEN120015 | Classification Order | Decision Summary |
| Infrascanner Model 1000 | DEN100002 | Classification Order | Decision Summary |
| Zeltiq™ Dermal Cooling Device | DEN090002 | Classification Order | |
| AirPurge System | DEN080009 | Classification Order | Decision Summary |
| Bio-Seal Lung Biopsy Tract Plug System | DEN090007 | Classification Order | Decision Summary |
| Erchonia ML Scanner | DEN090008 | Classification Order | |
| NuMED NuCLEUS and NuCLEUS-X BAV Catheters | DEN080015 | Classification Order | Decision Summary |
| Hem-Avert Perianal Stabilizer | DEN090011 | Classification Order | Decision Summary |
| RIDASCREEN Norovirus 3rd Generation EIA | DEN110001 | Classification Order | |
| Prostate Mechanical Imager | DEN100016 | Classification Order | Decision Summary |
| LipiFlow Thermal Pulsation System | DEN100017 | Classification Order | Decision Summary |
| Steris Verify Spore Test Strip for S40 | DEN110002 | Classification Order | Decision Summary |
| InBios DENV Detect IgM Capture ELISA | DEN100020 | Classification Order | Decision Summary |
| AHIP Internal Trigger Point Wand | DEN100023 | Classification Order | Decision Summary |
| Cabochon System | DEN110004 | Classification Order | Decision Summary |
| Widex C4-PA Wireless Air-Conduction Hearing Aid | DEN100025 | Classification Order | Decision Summary |
| Aptus Endovascular Suturing System | DEN100026 | Classification Order | Decision Summary |
| Restiffic™ Restless Leg Relaxer Foot Wrap | DEN110009 | Classification Order | Decision Summary |
| ImmunoCAP Tryptase | DEN120001 | Classification Order | Decision Summary |
| STRATIFY JCV Antibody ELISA | DEN120008 | Classification Order | Decision Summary |
| Neuropsychiatric EEG-Based Assessment Aid for ADHD (NEBA) System | DEN110019 | Classification Order | Decision Summary |
| Proteus Personal Monitor Including Ingestion Event Marker | DEN120011 | Classification Order | Decision Summary |
| PORTRAIT TOXIGENIC C. DIFFICILE ASSAY | DEN120013 | Classification Order | Decision Summary |
| Verigene® Gram Positive Blood Culture Nucleic Acid Test (BC-GP) | DEN120014 | Classification Order | Decision Summary |
| DEKA Arm System | DEN120016 | Classification Order | Decision Summary |
| COBAS INTEGRA 800 Tina-quant HbA1cDx Gen.2 assay | DEN130002 | Classification Order | Decision Summary |
| xTAG® Gastrointestinal Pathogen Panel (GPP) | DEN130003 | Classification Order | Decision Summary |
| Cefaly - Transcutaneous Electrical Nerve Stimulator | DEN120019 | Classification Order | Decision Summary |
| AXIOS Stent and Delivery System | DEN130007 | Classification Order | Decision Summary |
| X-ray Attenuating Cream | DEN120022 | Classification Order | Decision Summary |
| PillCam® COLON 2 Capsule Endoscopy System | DEN120023 | Classification Order | Decision Summary |
| Vysis EGR1 FISH Probe Kit | DEN130010 | Classification Order | Decision Summary |
| FerriScan R2-MRI Analysis System | DEN130012 | Classification Order | Decision Summary |
| VITEK®MS | DEN130013 | Classification Order | Decision Summary |
| NEPHROCHECK® Test System | DEN130031 | Classification Order | Decision Summary |
| Pixel 3 System | DEN130015 | Classification Order | Decision Summary |
| XSTAT | DEN130016 | Classification Order | Decision Summary |
| CytoScan® Dx Assay | DEN130018 | Classification Order | Decision Summary |
| Cerena Transcranial Magnetic Stimulator | DEN130022 | Classification Order | Decision Summary |
| NeoTract UroLift System, Model REF UL400 | DEN130023 | Classification Order | Decision Summary |
| Xpert MTB/RIF Assay | DEN130032 | Classification Order | Decision Summary |
| ReWalk™ | DEN130034 | Classification Order | Decision Summary |
| Prostate Immobilizer Rectal Balloon | DEN130036 | Classification Order | Decision Summary |
| EUROIMMUN Anti-PLA2R IFA | DEN140002 | Classification Order | Decision Summary |
| IOGYN System | DEN130040 | Classification Order | Decision Summary |
| Lyra™ Direct HSV 1 + 2/VZV Assay | DEN140004 | Classification Order | Decision Summary |
| Simplexa™ HSV 1 & 2 Direct | DEN130049 | Classification Order | Decision Summary |
| Lyra Direct Strep Assay | DEN140005 | Classification Order | Decision Summary |
| KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay | DEN140001 | Classification Order | Decision Summary |
| T2Candida Panel and T2Dx® Instrument | DEN140019 | Classification Order | Decision Summary |
| inFlow™ Intraurethral Valve-Pump and Activator | DEN130044 | Classification Order | Decision Summary |
| NaviCam Capsule Endoscope System with NaviCam Stomach Capsule | DEN190037 | Classification Order | Decision Summary |
| ToothWave™ | DEN190039 | Classification Order | Decision Summary |
| HemosIL Liquid Anti-Xa | DEN190032 | Classification Order | Decision Summary |
| Spineology Interbody Fusion System | DEN200010 | Classification Order | |
| Tangible Boost | DEN200002 | Classification Order | |
| BioFire Respiratory Panel 2.1 (RP2.1) | DEN200031 | Classification Order | Decision Summary |