Cleared 510(k) Submissions with Supporting Documents - 2024
This list includes cleared 510(k) submissions for 2024 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 |
|---|---|---|---|
| BK231036 | Haemonetics Corporation Boston, MA |
NexLynk DMS® Donor Management System 4.10.0 | 03/15/2024 |
| BK231035 | Terumo BCT Lakewood, CO |
Rika Plasma Donation System (V2.1) | 03/07/2024 |
| BK231016 | Aeon Biotherapeutics Corp. Taiwan |
Aeon ACKit | 02/16/2024 |