ClearanceBrief
Product code LKN ยท Class U

Separator, Automated, Blood Cell And Plasma, Therapeutic

0510(k)s in 12 months (27 all time)
0recalls in 12 months (12 all time)
11recalls that name a 510(k)
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Top companies in LKN

Company510(k)sRecalls
Fenwal, Inc.25
Terumobct, Inc.70
Caridianbct, Inc..22
Fresenius Kabi AG22
Caridian BCT, Incorporated02
Cobe Laboratories, Inc.20
Fresenius USA, Inc.20
Fresenius Medical Care North America20
Gambro Bct, Inc.11
Apheresis Technologies, Inc.10
Decided510(k)Device and applicantCode
Nov 13, 2019K192150AMICUS Separator System
Fresenius Kabi AG, DE
LKN
Feb 5, 2019K183081Spectra Optia Apheresis System
Terumobct, Inc.
LKN
Dec 4, 2018K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented
Fresenius Kabi USA,Llc
LKN
Nov 1, 2018K181049Spectra Optia Apheresis System
Terumobct, Inc.
LKN
Mar 2, 2018K172590Spectra Optia Apheresis System
Terumobct, Inc.
LKN
Jan 14, 2016K153601Spectra Optia Apheresis System
Terumobct, Inc.
LKN
Sep 11, 2015K151368Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter
Terumo Bct
LKN
Mar 23, 2015K141938SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)
Terumobct, Inc.
LKN
Jun 10, 2014K141019AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED
Fenwal, Inc.
LKN
Dec 6, 2013K132429SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET
Terumobct, Inc.
LKN
Aug 8, 2013K131744SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE
Terumobct, Inc.
LKN
Mar 22, 2012K111702AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE
Fenwal, Inc.
LKN
Jan 20, 2012K113480SPECTRA OPTIA APHERESIS SYSTEM
Caridianbct, Inc..
LKN
Nov 19, 2010K103090SPECTRA OPTIA R APHERESIS SYSTEM
Caridianbct, Inc..
LKN
Aug 2, 2007K071079SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200
Gambro Bct, Inc.
LKN
Sep 5, 2006K060734FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE)
Fresenius Medical Care North America
LKN
Jun 8, 2005K050273FRESENIUS ART HEMOADSORPTION SYSTEM
Fresenius Medical Care North America
LKN
Jul 31, 1996K961706P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR
Fresenius USA, Inc.
LKN
Jun 4, 1996K953681HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET
Haemonetics Corp.
LKN
Mar 2, 1993K926409PLASMA DISCARD BAGS
Apheresis Technologies, Inc.
LKN
Mar 22, 1991K900105COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC
Cobe Laboratories, Inc.
LKN
Nov 2, 1990K895435FRESENIUS AS 104 CELL SEPARATOR
Fresenius USA, Inc.
LKN
Oct 18, 1989K893962COBE 2991 SUPPLEMENTARY DISPOSABLE SETS
Cobe Laboratories, Inc.
LKN
Jan 27, 1988K874607FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS
Organon Teknika Corp.
LKN
May 16, 1985K850621GAMBRO PLASMAFILTRATION SYSTEM
Gambro, Inc.
LKN
Sep 12, 1983K831004AUTOMATED 8400 BLOOD CELL SEPARATOR
Intl. Business Machines
LKN
Jun 16, 1983K830831AUTOMATED BLOOD CELL SEPARATOR
Cryosan, Inc.
LKN

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