Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

MVN — Predicate Candidate Screening

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

72 daysmedian FDA review time

178 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K261812	HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact L	HOYA Lamphun , Ltd.	2026-07-07	36	0
K202448	DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Tori	Alcon Laboratories, Inc.	2020-09-22	27	0
K202036	Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progress	Alcon Laboratories, Inc.	2020-08-21	29	0
K150630	Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Con	Yung Sheng Optical Co., Ltd.	2015-06-15	96	0
K143190	Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophili	Yung Sheng Optical Co., Ltd.	2015-01-16	72	0
K130331	SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAIL	Sauflon Pharmaceuticals, Ltd.	2013-07-26	165	0
K112192	NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTE	Bausch & Lomb, Inc.	2011-10-25	88	0
K080632	CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS	Clearlab SG Pte, Ltd.	2008-10-15	224	0
K080755	SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TIN	Bausch & Lomb, Inc.	2008-06-10	85	0
K073060	CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR D	Innova Vision, Inc.	2007-11-29	30	0
K061948	PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONT	CooperVision, Inc.	2006-11-22	135	1
K061157	SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TI	Bausch & Lomb	2006-06-22	57	0
K052832	SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DIS	Sauflon Pharmaceuticals, Ltd.	2006-05-15	221	0
K053191	DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTAC	Innova Vision, Inc.	2006-05-12	178	0
K051900	ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY	Johnson & Johnson Vision Care, Inc.	2005-08-12	30	1
K050065	FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRES	Ciba Vision Corporation	2005-05-27	135	1
K050213	FRESHLOOK ONE-DAY COLOR CONTACT LENS	Ciba Vision Corporation	2005-03-28	56	0
K033701	FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRES	Ciba Vision Corporation	2003-12-15	20	0
K020389	BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTA	Ocular Sciences	2002-06-04	119	0
K011718	BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISI	Bausch & Lomb, Inc.	2001-07-25	51	0
K010636	FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOC	Ciba Vision Corporation	2001-03-23	18	0
K003826	FOCUS DAILIES PROGRESSIVES	Ciba Vision Corporation	2001-03-08	87	0
K003586	FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES	Ciba-Geigy Corp.	2001-02-08	80	0
K993252	METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55,	CooperVision, Inc.	1999-11-24	57	0
K992446	DAILIES (NELFILCON A) ONE-DAY	Ciba Vision Johns Creek Mfg.	1999-08-18	27	0
K984273	FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS	Ciba Vision Corporation	1999-01-25	56	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