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 |
|---|---|---|---|
| BK231039 | Delcon S.r.l. Italy | Giotto Monza (BCS03) | 3/26/2025 |
| BK251160 | Fresenius Kabi AG Lake Zurich, IL | Adaptive Nomogram Bottle | 2/21/2025 |
| BK241136 | BioLife Plasma Services LP Bannockburn, IL | Lookback Notification System version 2.0 | 2/20/2025 |
| BK241135 | Fresenius Kabi AG Lake Zurich, IL | Aurora Xi Plasmapheresis System Software Version 2.0 | 1/24/2025 |
| BK231018 | Sunphoria Co.,Ltd Taiwan | AHC Platelet Concentrate Separator | 1/10/2025 |
| BK241148 | Roche Diagnostics Indianapolis, IN | cobas pro serology solution (applicable to) a) Elecsys Syphilis and b) Elecsys Anti-CMV | 1/10/2025 |
| BK210601 | Immucor, Inc. Norcross, GA | Echo Lumena | 1/8/2025 |
| BK210604 | Immucor, Inc. Norcross, GA | Complement Control Cells | 1/8/2025 |
| BK210608 | Immucor, Inc. Norcross, GA | Galileo Echo | 1/8/2025 |
| BK241067 | Immucor GTI Diagnostics, Inc. Waukesha, WI | MatchX | 1/2/2025 |