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

Contamac, Ltd. — Predicate Candidate Screening

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

106 daysmedian FDA review time

167 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K212631	Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses	Contamac, Ltd.	2022-03-17	210	0
K182304	Hyper GP (tisilfocon A) Daily Wear Contact Lens	Contamac, Ltd.	2018-11-23	91	0
K181566	Nutrifill	Contamac, Ltd.	2018-10-22	130	1
K180616	OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact L	Contamac, Ltd.	2018-04-25	48	0
K171575	ENFLU 18 (enflufocon A) Daily Wear Contact Lens	Contamac, Ltd.	2017-10-24	147	0
K171077	HEXA100 (hexafocon A) Daily Wear Contact Lenses	Contamac, Ltd.	2017-08-01	112	0
K161100	Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wea	Contamac, Ltd.	2016-08-10	113	0
K160859	OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)	Contamac, Ltd.	2016-07-13	106	0
K150590	CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for	Contamac, Ltd.	2015-07-10	123	0
K081178	OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DA	Contamac, Ltd.	2008-10-09	167	0
K070628	OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.	Contamac, Ltd.	2007-05-01	55	0
K062548	MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CON	Contamac, Ltd.	2006-11-01	63	0
K033594	OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES	Contamac, Ltd.	2004-03-19	127	0
K023989	CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR D	Contamac, Ltd.	2003-02-26	86	0
K023987	CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAI	Contamac, Ltd.	2003-02-26	86	0
K024045	CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS	Contamac, Ltd.	2003-02-14	70	0
K023349	CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS	Contamac, Ltd.	2002-12-24	78	0
K021977	HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS F	Contamac, Ltd.	2002-09-12	87	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