2026 Biological Device Application Approvals
This list reflects information regarding the applications as of the approval/clearance date. It is not updated with regard to applicant or application status changes. The applications are listed in order by date of approval / clearance.
| Tradename/Common Name | Description and Indication for Device | Submission ID | Manufacturer | Clearance Date |
|---|---|---|---|---|
| RegenBMC® (RegenKit®-THT®-BMC) Automated blood cell separator | The RegenBMC® system is indicated to be used intraoperatively at the point-of-care for the safe and rapid preparation of autologous platelet concentrate platelet-rich plasma (PRP) from a small sample of peripheral blood or a small sample of a mixture of peripheral blood and bone marrow. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. | BK251274/0 | Regen Lab, USA, LLC -------(b)(4)------- ----(b)(4)---- ----------(b)(4)-------- ----(b)(4)- -------(b)(4)------- | 05/29/2026 |
| ELUclear Elution Kit Blood bank supplies | The ELUclear Elution Kit removes antibodies bound to red cell antigens through a controlled dissociated process. When antibody coated red cell antigens are exposed to an acidic elution solution, protonation of the antigen-antibody complex occurs, disrupting the electrostatic bonds between antibody and antigen. This pH-induced charge repulsion effectively dissociates the antibodies from the antigens. Following elution, the pH is restored to optimal conditions for serological testing, allowing further investigation of the recovered antibodies. | BK261315/0 | Hemo Bioscience, Inc. 4022 Stirrup Creek Drive, Suite 311 | 05/29/2026 |
| LIAISON® MUREX HIV Ab/Ag HT LIAISON® XL LIAISON® diluteX Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test | LIAISON® Murex HIV Ab/Ag HT The LIAISON® Murex HIV Ab/Ag HT is an in vitro chemiluminescent immunoassay for the simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (Groups M and O) and HIV-2 in human serum (without or with gel-SST) or plasma (lithium and sodium heparin, sodium citrate, and potassium EDTA), on the LIAISON® XL Analyzer or LIAISON® XS Analyzer. It is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1 and/or HIV-2 infection in pediatric subjects (2-21 years) and in pregnant women. The assay cannot distinguish between the detection of HIV p24 antigen and HIV-1/HIV-2 antibodies. The LIAISON® Murex HIV Ab/Ag HT assay is not intended for screening donors of blood or blood products, or human cells or tissues or cellular and tissue-based products (HCT/Ps), or organ donors for HIV. LIAISON® XL The LIAISON® XL Analyzer is a Diagnostic System that measures chemiluminescence. It is intended strictly for professional in-vitro Diagnostic use. It is to be used only with Chemiluminescence Immunoassays authorized by DiaSorin Italia S.p.A. for the LIAISON® XL instrument. The analyzer can be connected to a third-party Laboratory Automation System (LAS) which has been previously cleared for use with FDA cleared assays. LIAISON® diluteX The LIAISON® diluteX is an accessory for the LIAISON® XL analyzer. It is designed to automatically dilute the LIAISON® Wash/System Liquid with purified water and to distribute both the purified water and the diluted Wash/System Liquid (referred to as “Wash Buffer”) to each connected LIAISON® XL. The LIAISON® diluteX utilizes purified water (referred to as "sourced water"), which must be supplied to the device. The device automatically dilutes the concentrated Wash Buffer, stored on the device, with the sourced water and distributes both the diluted Wash/System Liquid and the sourced water to the LIAISON® XL via separate tubes directly into the analyzer’s tanks. For professional use only. | BK261335/0 | DiaSorin Inc. 1951 Northwestern Avenue | 05/29/2026 |
| Erytra Eflexis Automated blood grouping and antibody test system | Erytra Eflexis is a fully automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing DG Gel 8 cards technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Antibody Titration, Compatibility Tests, and Direct Antiglobulin Tests. As a standalone analyzer or interfaced to the customer’s Laboratory Information System (LIS), Erytra Eflexis automates test processing functions and data management requirements using DG Gel 8 cards and digital image processing. | BK261329/0 | Diagnostic Grifols, S.A. Passeig Fluvial, 24 08150 Parets del Vallès Spain | 05/21/2026 |
| ORTHO Optix™ Reader Automated blood grouping and antibody test system | The ORTHO Optix™ Reader is a system designed to automate reaction grading, results interpretation and data management when performing in vitro immunohematology testing of human blood utilizing ID-MTS™ Gel card technology. The ORTHO Optix™ Reader can be used as a standalone instrument or interfaced to the customer’s Laboratory Information System (LIS). | BK261331/0 | Ortho-Clinical Diagnostics, Inc. 1001 US Highway 202 Raritan, NJ 08869 | 05/13/2026 |
| Viality™ Lipoaspirate Wash System for Aesthetic Body Contouring (Viality-1400) Suction lipoplasty system | The Viality™ Lipoaspirate Wash System is to be used to filter and wash aspirated, harvested, autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted, the harvested fat is to be used without any additional manipulation. The Viality™ system may be used in processing harvested adipose tissue obtained in surgical specialties, including plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery. The Viality™ system is not intended to process autologous adipose tissue other than for aesthetic body contouring uses. | BK261326/0 | Tiger Aesthetics Medical, LLC 9630 S. 54 St. Franklin, Wisconsin 53132 | 05/13/2026 |
| Biowy Multi-Chamber Freezing Bag Set Container, Frozen Donor Tissue Storage | The Biowy Freezing Bag Set is intended for a single sequence of freezing, storage (in Liquid Nitrogen (-196°C)), and subsequent thawing (at +37°C) of hematopoietic progenitor cells. | BK261343/0 | Biowy Corporation 27031 Vista Terrace | 04/29/2026 |
| Plasmacell-C Disposable Set Automated blood cell separator | The Plasmacell-C disposable set is intended for collection of plasma by membrane filtration. | BK251289/0 | Fresenius Kabi AG Three Corporate Drive, 2nd Floor Lake Zurich, IL 60047 | 03/31/2026 |
| Procleix Plasmodium Quality Control Assayed quality control material for clinical microbiology assays | Procleix® Plasmodium Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from Plasmodium falciparum with the Procleix Plasmodium Assay. This product is intended to be used solely with the Procleix Plasmodium Assay, a licensed donor screening assay, performed on the Procleix Panther System. This product is not intended to replace manufacturer controls provided with the device. | BK251300/0 | Grifols Diagnostic Solutions Inc. 10808 Willow Court San Diego, CA 92127 | 03/26/2026 |
| PlateletQuick PRP Automated blood cell separator | The PlateletQuick PRP is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of peripheral blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. | BK251299/0 | Forever Labs, Inc 600 S Wagner Road Ann Arbor, MI 48103 | 03/11/2026 |
| Hemanext ONE Container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions | Blood container set used to process and store CP2D/AS-3 or ACD-A/AS-3 Red Blood Cells Leukocytes Reduced, O2/CO2 Reduced. The Hemanext ONE system limits O2 and CO2 levels in the storage environment. Hemanext ONE is intended to process the following: Whole Blood or Apheresis Derived CP2D/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have been filtered within 8-hours of collection. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 12 hours of collection. Apheresis Derived ACD-A/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have been filtered within 8-hours of collection. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 12 hours of collection. Whole Blood or Apheresis Derived CP2D/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have been filtered within 30 hours of collection at 1-6°C. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 72 hours of collection. Apheresis Derived ACD-A/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have been filtered within 30 hours of collection at 1-6°C. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 72 hours of collection. Apheresis Derived ACD-A/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have undergone in-line filtration and have been stored at 1-6°C for up to 67 hours. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 72 hours of collection. NOTE: REFER TO THE INSTRUCTIONS FOR USE TO SEE THE INFORMATION ABOVE IN TABULAR FORMAT. The Red Blood Cells must be processed with the Hemanext ONE system at room temperature (20-26°C). Red Blood Cells Leukocytes Reduced, O2/CO2 Reduced may be stored for up to 42 days at 1-6°C. The Hemanext ONE system is used for volumes no greater than 350 mL of LR RBC. | BK251294/0 | Hemanext Inc. 99 Hayden Avenue Building B, Suite 620 Lexington, MA 02421 | 03/06/2026 |
| NexSys PCS® Plasma Collection System with Persona Plus Technology Automated blood cell separator | The NexSys PCS® plasma collection system with Persona or Persona Plus Technology is intended for use as an automated cell separator system and blood component collector in conjunction with single-use sterile disposable sets, with or without saline compensation. Products that can be collected using the NexSys PCS® system include source plasma and plasma for transfusion. Using the 0625Q-00 bowl, the NexSys PCS® system with Express®Plus Technology is intended to collect source plasma only. | BK251292/0 | Haemonetics Corporation 125 Summer Street Boston, MA 02110 | 02/20/2026 |
| PRF-Matrix System Automated blood cell separator | Indications for Use: The PRF-Matrix system is intended to be used for the safe and rapid preparation of platelet-rich plasma (PRP) gel from a small sample of a patient’s own peripheral blood at point-of-care. Under the supervision of a healthcare professional, the PRP gel produced is topically applied for the management of cutaneous wounds such as diabetic ulcers, venous leg ulcers, and mechanically or surgically debrided wounds. | BK251232/0 | Royal Wound-X, Inc. MEDIcept, Inc. 200 Homer Avenue Ashland, MA 01721 | 02/20/2026 |
| PUREGRAFT SYNC Adipose Filtration System Suction lipoplasty system | The Puregraft SYNC Adipose Filtration System is a sterile, single-use, closed system. The system consists of a harvest canister containing a Puregraft filtration bag, which is filled through the lid manifold and inlet/waste tubing sets. The Puregraft SYNC System is used in-line with a vacuum or aspirator apparatus and a suitable liposuction cannula. The Puregraft SYNC System is indicated for use in the harvesting, filtering, and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring. | BK251296/0 | Bimini Health Tech 8400 Belleview Dr Suite 125, Plano, TX 75024 | 02/12/2026 |
Precise Cell Concentration System Automated blood cell separator | The Precise Cell Concentration System is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a mixture of peripheral blood and bone marrow aspirate (BMA) at the patient's point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect to improve handling characteristics. | BK251168/0 | Arteriocyte Medical Systems, Inc. DBA Isto Biologics 45 South Street, Suite 3 Hopkinton, MA 01748 | 02/03/2026 |
| Multichem ID-HIV p24 Assayed quality control material for clinical microbiological assays | Multichem ID-HIVp24 is intended for use as a qualitative quality control to monitor the precision of laboratory testing procedures for the HIV-1 p24 antigen detected by the heterogeneous immunoassay systems listed in the Instructions for Use. These products are not intended to replace manufacturer’s recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements. | BK251207/0
| Techno-Path Manufacturing Ltd. Fort Henry Business | 01/02/2026 |