Vaccines, Blood & Biologics

Cleared 510(k) Submissions with Supporting Documents - 2018

This list includes cleared 510(k) submissions for 2018 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) NumberApplicantDevice NameDecision Date
BK180293Fresenius Kabi AG
Lake Zurich, IL
Plasma Bottle with Locking Luer Adapter12/21/2018
BK180262Diagnostic Grifols, S.A.
Barcelona, Spain
DG Gel 8 Neutral12/20/2018
BK180260Diagnostic Grifols, S.A.
Barcelona, Spain
Erytra Eflexis®12/20/2018
BK180254Fresenius Kabi AG
Lake Zurich, IL
Glycerolyte 57 Solution, 400 mL; Glycerolyte 57 Solution, 500 mL12/3/2018
BK180266bioMérieux, Inc.
Hazelwood, MO
BACT/ALERT® BPA Culture Bottle; BACT/ALERT® BPN Culture Bottle11/29/2018
BK180188PuriBlood Medical Co. Ltd.
Taiwan (R.O.C.)
Leukocyte reduction filter for red blood cells11/23/2018
BK180278OriGen Biomedical, Inc.
Austin, TX
OriGen Cryostore Multi-Chamber Freezing Bags11/21/2018
BK180247Immucor, Inc.
Norcross, GA
BK180198ThermoGenesis, Inc.
Rancho Cordova, CA
AXP® II AutoXpress® Platform11/14/2018
BK180245Data Innovations LLC
South Burlington, VT
Instrument Manager V8.16.1011/8/2018
BK180243Immucor, Inc.
Norcross, GA
NEO Iris (Software Version 3.0)11/7/2018
BK180240Biomat USA, Inc.
Los Angeles, CA
GDS (Grifols Donation System), version 1.011/5/2018
BK180268Fresenius Kabi AG
Lake Zurich, IL
Aurora XI Plasmapheresis System, version 1.211/2/2018
BK180246Carter BloodCare
Bedford, TX
Blood Bank Information System (BBIMS) version 2.06.0011/1/2018
BK180232MAK-SYSTEM SA International Group
Paris, France
Patient Health Software (P.H.S) Version 2.010/18/2018
BK170092Progenika Biopharma, S. A.
BK180229Delcon S.R.L
HemoMix 3 with DCSX Software10/4/2018
BK180227Department of Veterans Affairs
Hines, IL
VistA Blood Establishment Computer (VBECS) Version 2.3.010/1/2018
BK180226Bio-Rad Medical Diagnostics GmbH
Redmond, WA
IH-Com V5.09/28/2018
BK180225Bio-Rad Medical Diagnostics GmbH
Redmond, WA
IH-Reader 249/28/2018
BK180219Medical Information Technology, Inc.
Westwood, MA
MEDITECH Expanse Blood Bank9/12/2018
BK180231Terumo BCT, Inc.
Lakewood, CO
Trima Accel® Automated Blood Collection System8/16/2018
BK180230Fresenius Kabi AG
Lake Zurich, IL
DXT Data Management System, Software Version 3.18/13/2018
BK180211Becton, Dickinson & Company
Sparks, MD
BD BACTEC™ Platelet Aerobic/F Culture vials; BD BACTEC™ Platelet Anaerobic/F Culture Vials8/8/2018
BK180209Haemonetics Corporation
Braintree, MA
SafeTrace Tx 4.0.08/7/2018
BK180220Immucor, Inc.
Norcross, GA
Galileo Echo®7/17/2018
BK180204Royal Biologics, LLCRoyal MaxxPRP Concentration System7/12/2018
BK180180Arthrex, Inc.
Naples, FL
Arthrex Angel System Kit7/5/2018
BK180200Mediware Information Systems, Inc.
Lenexa, KS
BK180181Immucor GTI Diagnostics, Inc.
Waukesha, WI
DonorScreen-HLA® Class I and Class II6/14/2018
BK170095RedDress Ltd
Philadelphia, PA
RD1 System6/14/2018
BK170150Biowy Corporation
Lake Forest, CA
Biowy Freezing Bags5/11/2018
BK170144Arthrex, Inc.
Naples, FL
Thrombinator System for use with the Arthrex Angel concentrated Platelet Rich Plasma (PRP) System5/10/2018
BK180175Bio-Rad Medical Diagnostic GmbH
Redmond, WA
TANGO infinity Software Version 1.55/1/2018
BK180174Bio-Rad Medical Diagnostic GmbH
Redmond, WA
IH-Com V5.05/1/2018
BK170135Immucor, Inc.
Norcross, GA
Echo Lumena™4/27/2018
BK170132Immucor, Inc.
Norcross, GA
Galileo Echo® (v.2.0)4/27/2018
BK170149Immunetics, Inc.
Boston, MA
BacTx® Bacterial Detection Kit4/16/2018
BK170157Terumo BCT, Inc.
Lakewood, CO
Trima Accel Blood Collection System4/6/2018
BK180185Haemonetics Corporation
Braintree, MA
PCS 300 Plasma Collection System3/27/2018
Minneapolis, MN
Neg Control2/2/2018
BK170142bioMerieux, Inc.
Hazelwood, MO
BacT/ALERT BPA Culture Bottle; BacT/ALERT BPN Culture Bottle2/1/2018
BK170138Ethicon Inc.
Somerville, NJ
EVICEL™ Laparoscopic Airless Spray Accessory (35cm Rigid)1/26/2018
BK170141Helmer Inc.
Noblesville, IN
UltraCW®II Automatic Cell Washing System1/22/2018
BK170162Grifols Diagnostic Solutions, Inc.
Emeryville, CA
Procleix Xpress® System (Software v3.0)1/18/2018
BK170108Alliance Partners, LLC
San Antonio, TX
Cyclone Concentrating System1/2/2018


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