Cleared 510(k) Submissions with Supporting Documents - 2020
This list includes cleared 510(k) submissions for 2020 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 |
|---|---|---|---|
| BK200530 | Becton, Dickinson and Company Sparks, MD |
BD BACTEC™ Platelet Aerobic/F Culture Vials BD BACTEC™ Platelet Anaerobic/F Culture Vials |
12/23/2020 |
| BK200531 | SCC Soft Computer Clearwater, FL |
SoftBank Version 25.6.1.0 | 12/18/2020 |
| BK200525 | NanoEntek, Inc. Westerly, RI |
ADAM-rWBC HT System | 12/1/2020 |
| BK200520 | EKF-diagnostic GmbH Barleben, Germany |
DiaSpect Tm system | 11/19/2020 |
| BK200519 | Holding Technologies, Inc. Royal Palm Beach, FL 33411 |
Maximus Processing System Blood PRP Kit | 11/19/2020 |
| BK200526 | Headspring Healthcare, Inc. Austin, TX |
National Donor Deferral Registry (NDDR) and Cross Donation Check System (CDCS) | 11/18/2020 |
| BK200513 | Hemasoft Software S.L. Nederland, CO |
e-Delphyn LIS Donor | 11/9/2020 |
| BK200517 | Biomat USA, Inc. Los Angeles, CA |
GDS (Grifols Donation System) V2.0 | 11/5/2020 |
| BK200515 | Hemasoft Software S.L. Nederland, CO |
e-Delphyn Donor version 11.0.0.1 | 11/5/2020 |
| BK200476 | Fujirebio Diagnostics, Inc. Malvern, PA |
PK CMV-PA System | 10/19/2020 |
| BK200512 | ARC-One Solutions, LLC Miramar, FL |
Regulated Software Application (RSA), Version 2.0 | 10/15/2020 |
| BK200502 | Immucor, Inc. Norcross, GA |
Galileo NEO | 10/13/2020 |
| BK200498 | Haemonetics Corporation Braintree, MA |
NexSys PCS® Plasma Collection System with Persona™ Technology | 10/2/2020 |
| BK200488 | Arlington Scientific, Inc. Springville, UT |
ASI Automated RPR test for Syphilis for use on the ASI Evolution | 9/30/2020 |
| BK200449 | Healeon Medical, Inc. Newbury Park, CA |
Healeon Duet | 8/6/2020 |
| BK200491 | Carter BloodCare Bedford, TX |
iWeBB electronic Laboratory Information System (iWeBB-eLIS) v1.0.0 | 7/29/2020 |
| BK190356 | Cryo-Cell International, Inc. Oldsmar, FL |
PrepaCyte®-CB Processing System | 6/17/2020 |
| BK200474 | Immucor, Inc. Norcross, GA |
NEO Iris | 6/12/2020 |
| BK200479 | WellSky Corporation Overland Park, KS |
WellSky Blood - Emergency Issue 2020 R1 | 6/12/2020 |
| BK200482 | Epic Systems Corporation San Francisco, CA |
Blood Product Administration Module Version 3-2020 | 6/10/2020 |
| BK200475 | Fenwal, Inc. Lake Zurich, IL |
ALYX Component Collection System | 6/10/2020 |
| BK190393 | Aeon Biotherapeutics Corp. Taiwan |
Aeon CPKit | 6/5/2020 |
| BK200472 | bioMérieux, Inc. Hazelwood, MO |
BACT/ALERT BPA Culture Bottle; BACT/ALERT BPN Culture Bottle | 5/20/2020 |
| BK200478 | Fresenius Kabi AG Lake Zurich, IL |
Aurora Xi Plasmapheresis System | 5/7/2020 |
| BK190313 | DIAGAST Minneapolis, MN |
PK System Control | 5/7/2020 |
| BK180292 | Beckman Coulter, Inc. Brea, CA |
PK7400 Automated Microplate System | 5/7/2020 |
| BK200467 | Grifols Diagnostics, S.A. Barcelona, Spain |
Erytra Eflexis® | 4/23/2020 |
| BK200456 | Kedrion SpA Fort Lee, NJ |
GeTraP | 4/20/2020 |
| BK190430 | CSL Plasma Boca Raton, FL |
Anti-D Donor Management and Inventory System (ADIMS) | 3/11/2020 |
| BK190421 | Fresenius Kabi AG Lake Zurich, IL |
Fenwal Plasmalink Transfer Pack Container with Luer Adapter and No Outlet Ports | 3/11/2020 |
| BK190434 | STRATEC Biomedical UK Limited United Kingdom |
ORTHO CONNECT™ 3.0 | 3/9/2020 |
| BK190317 | EmCyte Corporation Fort Myers, FL |
PurePRP SupraPhysiologic Concentrating System | 2/12/2020 |
| BK190413 | Fresenius Kabi AG Lake Zurich, IL |
CompoMat G5 Plus and CompoMaster Net G5 Plus System | 2/6/2020 |
| BK190429 | Delcon S.R.L. Italy |
HemoMix 4 (Basic version) and HemoMix 4 (Internal optional RFID installed version) | 1/30/2020 |
| BK190439 | Immucor GTI Diagnostics, Inc. Waukeshaha, WI |
MATCH IT!® DNA (version 1.3) | 1/21/2020 |