Cleared 510(k) Submissions with Supporting Documents - 2026

Cleared 510(k) Submissions with Supporting Documents - 2026 This list includes cleared 510(k) submissions for 2026 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 | |---|---|---|---| | BK251289 | Fresenius Kabi AG Lake Zurich, IL 60047 | Plasmacell-C Disposable Set | 03/31/2026 | | BK251300 | Grifols Diagnostic Solutions Inc. San Diego, CA 92127 | Procleix Plasmodium Quality Control | 03/26/2026 | | BK251299 | Forever Labs, Inc. Ann Arbor, MI 48103 | PlateletQuick PRP | 03/11/2026 | | BK251294 | Hemanext Inc. Lexington, MA 02421 | Hemanext ONE | 03/06/2026 | | BK251232 | Royal Wound-X, Inc. Hackensack, NJ 07061 | PRF-Matrix System | 02/20/2026 | | BK251292 | Haemonetics Corporation Boston, MA 02110 | NexSys PCS® Plasma Collection System with Persona Plus Technology | 02/20/2026 | | BK251296 | Bimini Health Tech Plano, TX 75024 | PUREGRAFT SYNC Adipose Filtration System | 02/12/2026 | | BK251168 | Arteriocyte Medical Systems, Inc. DBA Isto Biologics Hopkinton, MA 01748 | Precise Cell Concentration System | 02/03/2026 | | BK251207 | Techno-Path Manufacturing Ltd. Ireland | Multichem ID-HIV p24 | 01/02/2026 |