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 |
|---|---|---|---|
| BK241095 | Bimini Health Tech Plano, TX | Healeon Float PRP devices (HFPRP15, HFPRP30, and HFPRP45) | 11/20/2024 |
| BK241075 | Siemens Healthcare Diagnostics, Inc. Tarrytown, NY | Atellica® IM HIV Ag/Ab Combo (CHIV) | 11/7/2024 |
| BK241132 | Roche Diagnostics Indianapolis, IN | Elecsys Syphilis, Elecsys Anti-CMV, cobas pro serology solution | 11/6/2024 |
| BK241097 | Terumo BCT, Inc. Lakewood, CO | Rika Plasma Donation System (42000) | 11/5/2024 |
| BK241061 | IT Synergistics, LLC Flowood, MS | bexWISE API v1.0 | 10/25/2024 |
| BK241083 | OrthoAscent Ashland, MA | Platelet And Plasma Separator For Bone Graft Handling | 9/26/2024 |
| BK241042 | Gale Force Aesthetics, LLC Alamo, CA | Illuminate PRP | 8/27/2024 |
| BK241081 | Epic Systems Corporation Verona, WI | Blood Product Administration Module (BPAM 4-2023) | 8/21/2024 |
| BK241080 | Immucor, Inc. Norcross, GA | ImmuLINK (v3.2) | 8/6/2024 |
| BK231025 | Hologic, Inc. San Diego, CA | Aptima® HIV-1 Quant Dx Assay | 8/6/2024 |
| BK241074 | One Lambda, Inc. West Hills, CA | SeCore CDx HLA Sequencing System | 8/1/2024 |
| BK241069 | Carter BloodCare Bedford, TX | Blood Bank Information Management System (BBIMS) v3.01 | 7/9/2024 |
| BK241062 | Haemonetics Corporation Boston, MA | BloodTrack Software 4.16.0 | 6/21/2024 |
| BK231031 | NanoEntek, Inc. Korea | ADAMII CD34 System | 6/5/2024 |
| BK230958 | eDonorSoft, LLC Sugarland, TX | HemDonER 1.0.1 | 5/31/2024 |
| BK231013 | Musculoskeletal Transplant Foundation (MTF Biologics) Edison, NJ | LipoGrafter® Kit | 5/16/2024 |
| BK241060 | Arthrex, Inc. Naples, FL | Arthrex Thrombinator System | 4/24/2024 |
| BK230980 | Becton, Dickinson & Company Franklin Lakes, NJ | BD Vacutainer® K2EDTA Blood Collection Tubes | 4/17/2024 |
| BK230814 | Life Plasma, Inc. Reading, PA | SmartDMS | 4/16/2024 |
| BK230825 | Fresenius Kabi AG Lake Zurich, IL | ALYX 2RBC-LR Kit | 4/5/2024 |
| BK230968 | Reapplix ApS | 3C OrthoPatch Device | 3/29/2024 |
| 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 |