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

CooperVision, Inc. — Predicate Candidate Screening

97 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

72 daysmedian FDA review time

192 days90th percentile

97clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K234127	Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic),	CooperVision, Inc.	2024-01-25	28	0
K220070	MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Con	CooperVision, Inc.	2022-02-04	25	4
K213164	Avaira Vitality	CooperVision, Inc.	2021-10-26	28	0
K202756	Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilco	CooperVision, Inc.	2020-10-20	29	0
K191763	MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, My	CooperVision, Inc.	2020-03-23	266	0
K190965	MyDay	CooperVision, Inc.	2019-04-29	17	4
K181920	Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Dispos	CooperVision, Inc.	2018-12-11	146	1
K160803	Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens	CooperVision, Inc.	2016-07-13	112	0
K133627	AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS	CooperVision, Inc.	2013-12-23	27	0
K131378	SUS (STENFILCON A) CONTACT LENS	CooperVision, Inc.	2013-08-30	108	5
K123202	PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS	CooperVision, Inc.	2013-05-30	230	1
K113759	AVAIRA (ENFILCON A) CONTACT LENS	CooperVision, Inc.	2012-04-03	104	1
K112302	PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOC	CooperVision, Inc.	2011-12-21	132	0
K113267	BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC	CooperVision, Inc.	2011-12-02	28	0
K113245	AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL	CooperVision, Inc.	2011-12-02	30	0
K111966	PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY	CooperVision, Inc.	2011-09-15	66	0
K110099	PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR	CooperVision, Inc.	2011-06-29	167	0
K091339	BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS	CooperVision, Inc.	2010-01-05	244	1
K081865	PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR	CooperVision, Inc.	2008-09-29	90	0
K071736	AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS	CooperVision, Inc.	2008-01-04	192	2
K061948	PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONT	CooperVision, Inc.	2006-11-22	135	1
K052560	BIOFINITY (COMFILCON A) SOFT CONTACT LENS	CooperVision, Inc.	2005-12-06	81	0
K050717	PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCL	CooperVision, Inc.	2005-05-13	53	0
K042824	FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CO	CooperVision, Inc.	2004-11-16	35	0
K042435	COOPER PROSTHETIC	CooperVision, Inc.	2004-10-26	48	0
K041138	LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS	CooperVision, Inc.	2004-07-23	84	0
K032873	PROCLEAR COMPATIBLES MULTIFOCAL	CooperVision, Inc.	2003-11-07	53	0
K020392	FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LE	CooperVision, Inc.	2002-04-26	79	0
K002625	METHAFILCON A	CooperVision, Inc.	2000-09-13	21	0
K001090	METHAFILCON A	CooperVision, Inc.	2000-05-19	45	0
K001089	POLYMACON	CooperVision, Inc.	2000-05-19	45	0
K000384	FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, O	CooperVision, Inc.	2000-03-06	28	0
K993252	METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55,	CooperVision, Inc.	1999-11-24	57	0
K990606	TETRAFILCON A	CooperVision, Inc.	1999-03-15	20	0
K980649	PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERC	CooperVision, Inc.	1998-05-13	83	0
K963013	PREFERENCE 60 AND PREFERENCE 60 TORIC	CooperVision, Inc.	1997-12-19	507	0
K962185	HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) D	CooperVision, Inc.	1996-12-17	194	1
K954139	AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTA	CooperVision, Inc.	1995-11-24	84	0
K950968	TETRAFILCON A HYDROPHILIC CONTACT LENSES	CooperVision, Inc.	1995-07-25	146	0
K890635	CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV.	CooperVision, Inc.	1989-05-09	90	0
K890300	INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE	CooperVision, Inc.	1989-04-17	88	0
K882372	RESUBMITTED DIODE LASER COAGULATOR	CooperVision, Inc.	1988-08-02	68	0
K881095	KOI(TM) INSTRUMENT TRAYS	CooperVision, Inc.	1988-04-06	22	0
K881094	KOI(TM) BLADE GAUGE, MODEL KOI-132	CooperVision, Inc.	1988-04-01	17	0
K872214	COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS	CooperVision, Inc.	1987-08-17	69	0
K871854	IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS	CooperVision, Inc.	1987-07-27	75	0
K871871	SERIES TEN THOUSAND OCUTOME	CooperVision, Inc.	1987-06-11	29	0
K871440	KRATZ NOVA-SERT	CooperVision, Inc.	1987-05-07	24	0
K870265	KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR	CooperVision, Inc.	1987-02-20	28	0
K864336	PACHYMETER SYSTEM V	CooperVision, Inc.	1987-01-09	66	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