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  1. Substantially Equivalent 510(k) Device Information

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
BK200531 SCC Soft Computer
Clearwater, FL
SoftBank Version 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 11/5/2020
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.
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
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.
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


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