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) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| BK180293 | Fresenius Kabi AG Lake Zurich, IL |
Plasma Bottle with Locking Luer Adapter | 12/21/2018 |
| BK180262 | Diagnostic Grifols, S.A. Barcelona, Spain |
DG Gel 8 Neutral | 12/20/2018 |
| BK180260 | Diagnostic Grifols, S.A. Barcelona, Spain |
Erytra Eflexis | 12/20/2018 |
| BK180254 | Fresenius Kabi AG Lake Zurich, IL |
Glycerolyte 57 Solution, 400 mL; Glycerolyte 57 Solution, 500 mL | 12/3/2018 |
| BK180266 | bioMérieux, Inc. Hazelwood, MO |
BACT/ALERT® BPA Culture Bottle; BACT/ALERT® BPN Culture Bottle | 11/29/2018 |
| BK180188 | PuriBlood Medical Co. Ltd. Taiwan (R.O.C.) |
Leukocyte reduction filter for red blood cells | 11/23/2018 |
| BK180278 | OriGen Biomedical, Inc. Austin, TX |
OriGen Cryostore Multi-Chamber Freezing Bags | 11/21/2018 |
| BK170136 | Healeon Medical, Inc. Newbury Park, CA |
Healeon HD PRP | 11/21/2018 |
| BK180247 | Immucor, Inc. Norcross, GA |
Capture-CMV | 11/20/2018 |
| BK180198 | ThermoGenesis, Inc. Rancho Cordova, CA |
AXP® II AutoXpress® Platform | 11/14/2018 |
| BK180245 | Data Innovations LLC South Burlington, VT |
Instrument Manager V8.16.10 | 11/8/2018 |
| BK180243 | Immucor, Inc. Norcross, GA |
NEO Iris (Software Version 3.0) | 11/7/2018 |
| BK180240 | Biomat USA, Inc. Los Angeles, CA |
GDS (Grifols Donation System), version 1.0 | 11/5/2018 |
| BK180268 | Fresenius Kabi AG Lake Zurich, IL |
Aurora XI Plasmapheresis System, version 1.2 | 11/2/2018 |
| BK180246 | Carter BloodCare Bedford, TX |
Blood Bank Information System (BBIMS) version 2.06.00 | 11/1/2018 |
| BK180232 | MAK-SYSTEM SA International Group Paris, France |
Patient Health Software (P.H.S) Version 2.0 | 10/18/2018 |
| BK170092 | Progenika Biopharma, S. A. Spain |
ID CORE CONTROL | 10/11/2018 |
| BK180229 | Delcon S.R.L Italy |
HemoMix 3 with DCSX Software | 10/4/2018 |
| BK180227 | Department of Veterans Affairs Hines, IL |
VistA Blood Establishment Computer (VBECS) Version 2.3.0 | 10/1/2018 |
| BK180226 | Bio-Rad Medical Diagnostics GmbH Redmond, WA |
IH-Com V5.0 | 9/28/2018 |
| BK180225 | Bio-Rad Medical Diagnostics GmbH Redmond, WA |
IH-Reader 24 | 9/28/2018 |
| BK180219 | Medical Information Technology, Inc. Westwood, MA |
MEDITECH Expanse Blood Bank | 9/12/2018 |
| BK180231 | Terumo BCT, Inc. Lakewood, CO |
Trima Accel® Automated Blood Collection System | 8/16/2018 |
| BK180230 | Fresenius Kabi AG Lake Zurich, IL |
DXT Data Management System, Software Version 3.1 | 8/13/2018 |
| BK180211 | Becton, Dickinson & Company Sparks, MD |
BD BACTEC™ Platelet Aerobic/F Culture vials; BD BACTEC™ Platelet Anaerobic/F Culture Vials | 8/8/2018 |
| BK180209 | Haemonetics Corporation Braintree, MA |
SafeTrace Tx 4.0.0 | 8/7/2018 |
| BK180220 | Immucor, Inc. Norcross, GA |
Galileo Echo® | 7/17/2018 |
| BK180204 | Royal Biologics, LLC | Royal MaxxPRP Concentration System | 7/12/2018 |
| BK180180 | Arthrex, Inc. Naples, FL |
Arthrex Angel System Kit | 7/5/2018 |
| BK180200 | Mediware Information Systems, Inc. Lenexa, KS |
LifeTrak®2018 | 7/3/2018 |
| BK180181 | Immucor GTI Diagnostics, Inc. Waukesha, WI |
DonorScreen-HLA® Class I and Class II | 6/14/2018 |
| BK170095 | RedDress Ltd Philadelphia, PA |
RD1 System | 6/14/2018 |
| BK170150 | Biowy Corporation Lake Forest, CA |
Biowy Freezing Bags | 5/11/2018 |
| BK170144 | Arthrex, Inc. Naples, FL |
Thrombinator System for use with the Arthrex Angel concentrated Platelet Rich Plasma (PRP) System | 5/10/2018 |
| BK180175 | Bio-Rad Medical Diagnostic GmbH Redmond, WA |
TANGO infinity Software Version 1.5 | 5/1/2018 |
| BK180174 | Bio-Rad Medical Diagnostic GmbH Redmond, WA |
IH-Com V5.0 | 5/1/2018 |
| BK170135 | Immucor, Inc. Norcross, GA |
Echo Lumena™ | 4/27/2018 |
| BK170132 | Immucor, Inc. Norcross, GA |
Galileo Echo® (v.2.0) | 4/27/2018 |
| BK170149 | Immunetics, Inc. Boston, MA |
BacTx® Bacterial Detection Kit | 4/16/2018 |
| BK170157 | Terumo BCT, Inc. Lakewood, CO |
Trima Accel Blood Collection System | 4/6/2018 |
| BK180185 | Haemonetics Corporation Braintree, MA |
PCS 300 Plasma Collection System | 3/27/2018 |
| BK160084 | Diagast Minneapolis, MN |
Neg Control | 2/2/2018 |
| BK170142 | bioMerieux, Inc. Hazelwood, MO |
BacT/ALERT BPA Culture Bottle; BacT/ALERT BPN Culture Bottle | 2/1/2018 |
| BK170138 | Ethicon Inc. Somerville, NJ |
EVICEL™ Laparoscopic Airless Spray Accessory (35cm Rigid) | 1/26/2018 |
| BK170141 | Helmer Inc. Noblesville, IN |
UltraCW®II Automatic Cell Washing System | 1/22/2018 |
| BK170162 | Grifols Diagnostic Solutions, Inc. Emeryville, CA |
Procleix Xpress® System (Software v3.0) | 1/18/2018 |
| BK170108 | Alliance Partners, LLC San Antonio, TX |
Cyclone Concentrating System | 1/2/2018 |