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 |
|---|---|---|---|---|
| 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 |