ORG · Platelet And Plasma Separator For Bone Graft Handling
Hematology · 21 CFR 864.9245 · Class 2
Overview
| Product Code | ORG |
|---|---|
| Device Name | Platelet And Plasma Separator For Bone Graft Handling |
| Regulation | 21 CFR 864.9245 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
An automated blood cell separator is a device that uses a centrifugal or filtration separation principle to automatically withdraw whole blood from a donor, separate the whole blood into blood components, collect one or more of the blood components, and return to the donor the remainder of the whole blood and blood components. The automated blood cell separator device is intended for routine collection of blood and blood components for transfusion or further manufacturing use.
Classification Rationale
Class II (special controls). The special control for this device is a guidance for industry and FDA staff entitled “Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is a guidance for industry and FDA staff entitled “Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle.”
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| BK251274 | RegenBMC® (RegenKit®-THT®-BMC) | Regen Lab, USA, LLC Jersey City, NJ 07302 | May 29, 2026 | SESE |
| BK251299 | PlateletQuick PRP | Forever Labs, Inc. Ann Arbor, MI 48103 | Mar 11, 2026 | SESE |
| BK251168 | Precise Cell Concentration System | Arteriocyte Medical Systems, Inc. DBA Isto Biologics Hopkinton, MA 01748 | Feb 3, 2026 | SESE |
| BK251248 | PRiSM PRP | Bahia Medical Plano, TX 75024 | Dec 23, 2025 | SESE |
| BK251201 | DR.PRP-30 | Rmedical Co., Ltd | Oct 8, 2025 | SESE |
| BK251157 | ENDORET® Kit | B.T.I. Biotechnology Institute, S.L. Miñano (Álava), Spain | Oct 3, 2025 | SESE |
| BK251196 | Exocube Set | StemC Biyoteknoloji Anonim Sirketi New Smyrna Beach, FL 32168 | Aug 28, 2025 | SESE |
| BK231018 | AHC Platelet Concentrate Separator | Sunphoria Co.,Ltd Taiwan | Jan 10, 2025 | SESE |
| BK241095 | Healeon Float PRP devices (HFPRP15, HFPRP30, and HFPRP45) | Bimini Health Tech Plano, TX | Nov 20, 2024 | SESE |
| BK241083 | Platelet And Plasma Separator For Bone Graft Handling | OrthoAscent Ashland, MA | Sep 26, 2024 | SESE |
| BK241042 | Illuminate PRP | Gale Force Aesthetics, LLC Alamo, CA | Aug 27, 2024 | SESE |
| BK241060 | Arthrex Thrombinator System | Arthrex, Inc. Naples, FL | Apr 24, 2024 | SESE |
| BK230968 | 3C OrthoPatch Device | Reapplix ApS | Mar 29, 2024 | SESE |
| BK231016 | Aeon ACKit | Aeon Biotherapeutics Corp. Taiwan | Feb 16, 2024 | SESE |
| BK230844 | nSTRIDE® PRP Concentration System | Biomet Biologics, Inc. Warsaw, IN | Aug 9, 2023 | SESE |
| BK230818 | Dr. PRP | YTS Global Inc. Springfield, VA | May 31, 2023 | SESE |
| BK230807 | Adaptive Autologous Processing System | Genesis Biologics, Inc. | May 10, 2023 | SESE |
Top Applicants
- Aeon Biotherapeutics Corp. Taiwan — 1 clearance
- Arteriocyte Medical Systems, Inc. DBA Isto Biologics Hopkinton, MA 01748 — 1 clearance
- Arthrex, Inc. Naples, FL — 1 clearance
- B.T.I. Biotechnology Institute, S.L. Miñano (Álava), Spain — 1 clearance
- Bahia Medical Plano, TX 75024 — 1 clearance
