Cleared 510(k) Submissions with Supporting Documents - 2025
This list includes cleared 510(k) submissions for 2025 for which we have supporting documents available and reflects the information as of the clearance date. It is not updated with regard to applicant or application status change.
The clearances are listed by clearance date in reverse chronological order.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| BK251248 | Bahia Medical Plano, TX 75024 | PRiSM PRP | 12/23/2025 |
| BK251197 | HsingChi Medical Ltd. TAIWAN | “HsingChi” LipoSelector Disposable Fat Collection System (LS-1200) | 12/23/2025 |
| BK251285 | Roche Diagnostics Indianapolis, IN 46250 | Elecsys Syphilis | 12/10/2025 |
| BK251286 | Roche Molecular Systems, Inc Pleasanton, CA 94588 | a) cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems b) cobas® HIV-1/HIV-2 Qualitative Nucleic acid test for use on the cobas® 5800/6800/8800 systems | 11/21/2025 |
| BK251268 | Synova Life Sciences, Inc. Los Angeles, CA 90032 | Synova Wave Adipose Processing System | 11/17/2025 |
| BK251272 | Alba Bioscience Limited United Kingdom | Alba Elution Kit | 11/14/2025 |
| BK251265 | Alba Bioscience Limited United Kingdom | ORTHO® Elution Kit | 11/12/2025 |
| BK251174 | MimiX Biotherapeutics, Ltd | FastSkin Patch | 11/07/2025 |
| BK251238 | Ortho-Clinical Diagnostics, Inc. | ORTHO VISION® Analyzer and ORTHO VISION® Max Analyzer | 10/10/2025 |
| BK251256 | Immucor, Inc. Norcross, Georgia 30071 | ImmuLINK (v3.3) | 10/24/2025 |
| BK251237 | Micro Typing Systems, Inc. | DAT Control (MTSTM DAT Card) | 10/10/2025 |
| BK251280 | Roche Diagnostics Indianapolis, IN 46250 | cobas pro serology solution (applicable to) Elecsys Syphilis and Elecsys Anti-CMV | 10/09/2025 |
| BK251201 | Rmedical Co., Ltd | DR.PRP-30 | 10/08/2025 |
| BK251157 | B.T.I. Biotechnology Institute, S.L. Miñano (Álava), Spain | ENDORET® Kit | 10/03/2025 |
| BK251241 | Haemonetics Corporation Boston, MA 02110 | SafeTrace Tx® Software 5.0.0 | 09/10/2025 |
| BK251196 | StemC Biyoteknoloji Anonim Sirketi New Smyrna Beach, FL 32168 | Exocube Set | 08/28/2025 |
| BK251234 | Abbott Molecular Des Plaines, IL 60018 | Alinity m HIV-1 AMP Kit Alinity m HIV-1 CTRL Kit Alinity m HIV-1 CAL Kit Alinity m HIV-1 Application Specification File | 08/27/2025 |
| BK251254 | Bio-Rad Laboratories, Inc Woodinville, WA 98072 | Geenius™ HIV 1/2 Supplemental Assay | 08/26/2025 |
| BK251199 | EUROMI S.A Belgium | NLF system® kit 2 (EUROMI) | 08/14/2025 |
| BK251235 | Roche Molecular Systems, Inc Pleasanton, CA 94588 | cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems | 07/01/2025 |
| BK251233 | Roche Molecular Systems, Inc Pleasanton, CA 94588 | cobas® HIV-1/HIV-2 Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 systems | 06/27/2025 |
| BK251184 | Diagnostic Grifols, S.A. Barcelona, Spain | DG Gel 8 Neutral card | 06/17/2025 |
| BK251183 | Diagnostic Grifols, S.A. Barcelona, Spain | Erytra | 06/17/2025 |
| BK251182 | Diagnostic Grifols, S.A. Barcelona, Spain | Erytra Eflexis | 06/17/2025 |
| BK251188 | MAK-SYSTEM Group Ltd. London United Kingdom | Patient Health Software (P.H.S) v11.0.0.0 | 06/11/2025 |
| BK241116 | DiaSorin, Inc. Stillwater, MN | LIAISON® MUREX HIV Ab-Ag HT and LIAISON® MUREX Control HIV Ab-Ag HT | 06/10/2025 |
| BK241079 | Innoveren Scientific, Inc. Cincinnati, OH | Peripheral blood processing device for wound management | 03/28/2025 |
| BK231039 | Delcon S.r.l. Italy | Giotto Monza (BCS03) | 03/26/2025 |
| BK251160 | Fresenius Kabi AG Lake Zurich, IL | Adaptive Nomogram Bottle | 02/21/2025 |
| BK241136 | BioLife Plasma Services LP Bannockburn, IL | Lookback Notification System version 2.0 | 02/20/2025 |
| BK241135 | Fresenius Kabi AG Lake Zurich, IL | Aurora Xi Plasmapheresis System Software Version 2.0 | 01/24/2025 |
| BK231018 | Sunphoria Co.,Ltd Taiwan | AHC Platelet Concentrate Separator | 01/10/2025 |
| BK241148 | Roche Diagnostics Indianapolis, IN | cobas pro serology solution (applicable to) a) Elecsys Syphilis and b) Elecsys Anti-CMV | 01/10/2025 |
| BK210601 | Immucor, Inc. Norcross, GA | Echo Lumena | 01/08/2025 |
| BK210604 | Immucor, Inc. Norcross, GA | Complement Control Cells | 01/08/2025 |
| BK210608 | Immucor, Inc. Norcross, GA | Galileo Echo | 01/08/2025 |
| BK241067 | Immucor GTI Diagnostics, Inc. Waukesha, WI | MatchX | 01/02/2025 |