Cleared 510(k) Submissions with Supporting Documents - 2022
This list includes cleared 510(k) submissions for 2022 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 |
|---|---|---|---|
| BK220788 | Fresenius Kabi AG Lake Zurich, IL |
Aurora Xi Plasmapheresis System | 12/23/2022 |
| BK220767 | StemC Biotechnology, Inc. New Smyrna Beach, FL |
Lipocube Nano, Liopcube Hybrid I, Lipocube Hybrid II, Centrifuge Container | 12/21/2022 |
| BK220785 | Fresenius Kabi AG Lake Zurich, IL |
Transfer Packs | 12/20/2022 |
| BK220769 | Bio-Rad Medical Diagnostics GmbH Dreieich, Germany |
IH-AbID | 12/7/2022 |
| BK220738 | Diagnostic Grifols, S.A. Spain |
DG Reader Net | 12/7/2022 |
| BK220754 | Diagnostic Grifols, S.A. Spain |
DG Gel 8 Neutral | 11/1/2022 |
| BK220753 | Diagnostic Grifols, S.A. Spain |
DG Reader Net | 11/1/2022 |
| BK220752 | Diagnostic Grifols, S.A. Spain |
Erytra Eflexis | 11/1/2022 |
| BK220751 | Diagnostic Grifols, S.A. Spain |
Erytra | 11/1/2022 |
| BK220673 | Wuhan BMS Medicaltech Co., Ltd China |
Sterile Tube Welder (Model: STW6810-RFID) | 10/24/2022 |
| BK220746 | Grifols Diagnostic Solutions Inc. Emeryville, CA |
Procleix® WNV/Babesia Quality Control | 10/14/2022 |
| BK220744 | Diagnostic Grifols, S. A. Spain |
Blood Typing Manager | 10/4/2022 |
| BK220762 | Immucor GTI Diagnostics, Inc. Waukesha, WI |
MATCH IT!® Antibody | 9/29/2022 |
| BK220763 | Immucor GTI Diagnostics, Inc. Waukesha, WI |
LIFECODES LifeScreen XP | 9/29/2022 |
| BK210655 | Arthrex, Inc. Naples, FL |
Arthrex Autologous Conditioned Plasma (ACP) Max™ PRP System | 9/22/2022 |
| BK220736 | Grifols Diagnostic Solutions Inc. Emeryville, CA |
Procleix® HIV-1/HCV/HBV Quality Control | 9/16/2022 |
| BK220750 | THIEBAUD SAS Paris, France |
st’rim, macro st'rim, mini st’rim and nano st’rim | 8/26/2022 |
| BK210658 | Terumo BCT, Inc. Lakewood, CO 80215 |
IMUGARD® WB PLT Platelet Pooling Set | 8/26/2022 |
| BK220670 | Immucor, Inc. Norcross, GA |
Galileo NEO® | 7/26/2022 |
| BK220669 | Immucor, Inc. Norcross, GA |
NEO Iris® | 7/26/2022 |
| BK210584 | GenesisBPS, LLC Ramsey, NJ |
Genesis RapidWeld II STW, model GRW-430-02 | 7/15/2022 |
| BK210661 | RegenLab SA Avon, Minnesota |
RegenKit-Wound Gel-2 | 7/8/2022 |
| BK220724 | Ortho-Clinical Diagnostics, Inc. Raritan, NJ |
ORTHO Optix™ Reader | 6/24/2022 |
| BK210653 | Millipore (UK) Ltd. United Kingdom |
ORTHO™ Daily QC Simulated Whole Blood Quality Control Kit | 6/7/2022 |
| BK210631 | Sysmex America, Inc. Lincolnshire, IL |
Sysmex XN-10 Automated Hematology Analyzer | 5/23/2022 |
| BK200540 | Arteriocyte Medical Systems, Inc. Hopkinton, MA |
Precise Cell Concentration System | 3/17/2022 |
| BK220674 | MicroAire Surgical Instruments, LLC. Charlottesville, VA |
MicroAire LipoFilter® System | 3/16/2022 |
| BK210635 | Terumo BCT, Inc. Lakewood, CO |
Rika Plasma Donation System; Rika Plasma Separation Set; Rika Plasma Bottle | 3/7/2022 |
| BK210625 | Bio-Rad Medical Diagnostics GmbH Dreieich, Germany |
IH-500 | 2/28/2022 |
| BK210632 | Royal Biologics, Inc. Hackensack, NJ |
Royal MAXX PRP Concentration System | 2/11/2022 |
| BK210591 | Terumo BCT, Inc Lakewood, CO |
Platelet-Rich Plasma (PRP) Procedure Pack | 2/11/2022 |
| BK210652 | Becton, Dickinson and Company San Jose, CA |
BD® Stem Cell Enumeration Kit | 1/27/2022 |
| BK210650 | CSL Plasma Knoxville, TN |
LOGIC 4.0.8 | 1/25/2022 |
| BK210649 | Becton, Dickinson & Company Franklin Lakes, NJ |
BD Vacutainer ACD A Blood Collection Tube; BD Vacutainer ACD B Blood Collection Tube | 1/21/2022 |