Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

LKN — Predicate Candidate Screening

27 FDA 510(k) clearances under this product code; the 50 most recent screened below.

113 daysmedian FDA review time

302 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K192150	AMICUS Separator System	Fresenius Kabi AG	2019-11-13	96	0
K183081	Spectra Optia Apheresis System	Terumobct, Inc.	2019-02-05	91	0
K180615	AMICUS Separator System, AMICUS Exchange Kit - Therapeutics,	Fresenius Kabi USA,Llc	2018-12-04	271	2
K181049	Spectra Optia Apheresis System	Terumobct, Inc.	2018-11-01	195	0
K172590	Spectra Optia Apheresis System	Terumobct, Inc.	2018-03-02	185	0
K153601	Spectra Optia Apheresis System	Terumobct, Inc.	2016-01-14	29	0
K151368	Spectra Optia Apheresis System, Spectra Optia Exchange Set (	Terumo Bct	2015-09-11	113	0
K141938	SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (	Terumobct, Inc.	2015-03-23	249	0
K141019	AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED	Fenwal, Inc.	2014-06-10	50	0
K132429	SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWAR	Terumobct, Inc.	2013-12-06	123	0
K131744	SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE	Terumobct, Inc.	2013-08-08	56	0
K111702	AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE	Fenwal, Inc.	2012-03-22	279	1
K113480	SPECTRA OPTIA APHERESIS SYSTEM	Caridianbct, Inc..	2012-01-20	58	0
K103090	SPECTRA OPTIA R APHERESIS SYSTEM	Caridianbct, Inc..	2010-11-19	31	4
K071079	SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET,	Gambro Bct, Inc.	2007-08-02	107	4
K060734	FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; F	Fresenius Medical Care North America	2006-09-05	169	0
K050273	FRESENIUS ART HEMOADSORPTION SYSTEM	Fresenius Medical Care North America	2005-06-08	121	0
K961706	P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE	Fresenius USA, Inc.	1996-07-31	90	1
K953681	HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET	Haemonetics Corp.	1996-06-04	302	0
K926409	PLASMA DISCARD BAGS	Apheresis Technologies, Inc.	1993-03-02	71	0
K900105	COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC	Cobe Laboratories, Inc.	1991-03-22	437	0
K895435	FRESENIUS AS 104 CELL SEPARATOR	Fresenius USA, Inc.	1990-11-02	421	0
K893962	COBE 2991 SUPPLEMENTARY DISPOSABLE SETS	Cobe Laboratories, Inc.	1989-10-18	138	0
K874607	FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS	Organon Teknika Corp.	1988-01-27	79	0
K850621	GAMBRO PLASMAFILTRATION SYSTEM	Gambro, Inc.	1985-05-16	90	0
K831004	AUTOMATED 8400 BLOOD CELL SEPARATOR	Intl. Business Machines	1983-09-12	167	0
K830831	AUTOMATED BLOOD CELL SEPARATOR	Cryosan, Inc.	1983-06-16	92	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda