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

MRC · Predicate Candidate Screening

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

84 daysmedian FDA review time

202 days90th percentile

33clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K251876	cleadew GP hydra one	Ophtecs Corporation	2025-10-09	113	0
K200416	Boston One Step Liquid Enzymatic Cleaner	Bausch & Lomb, Incorporated	2020-09-23	216	0
K201069	VibrantVue Scleral Saline	Dry Eye Innovations, LLC	2020-07-31	100	0
K182984	MaxiTears Contacts PF	Omnivision AG	2019-07-24	268	0
K181566	Nutrifill	Contamac, Ltd.	2018-10-22	130	1
K181627	Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch +	Bausch & Lomb, Incorporated	2018-08-10	51	0
K180319	Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston A	Bausch and Lomb, Incorporated	2018-03-27	50	0
K173089	Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston	Bausch & Lomb, Incorporated	2017-11-27	59	0
K173136	Menicon Progent Protein Remover for Rigid Gas Permeable Cont	Menicon Co, Ltd.	2017-11-16	48	0
K130805	MENICON UNIQUE PH MULTI-PURPOSE SOLUTION	Menicon Co, Ltd.	2013-07-03	100	0
K122273	MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONT	Menicon Co, Ltd.	2013-01-02	156	0
K082855	MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONT	Menicon Co, Ltd.	2010-03-09	526	0
K052074	JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND S	Szabocsik and Associates	2005-09-01	31	0
K040839	COMPLETE BLINK-N-CLEAN LENS DROPS	Advanced Medical Optics, Inc.	2004-10-19	202	0
K024289	BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION	Bausch & Lomb, Incorporated	2003-05-02	130	0
K023455	AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION	Ciba Vision Corporation	2003-02-28	136	0
K020930	MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS	Menicon Co, Ltd.	2002-05-02	41	0
K013204	AQUIFY LENS COMFORT DROPS	Ciba Vision Corporation	2002-04-03	190	1
K014162	MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND	Lobob Laboratories, Inc.	2002-01-15	27	0
K011456	DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONT	Sauflon Pharmaceuticals, Ltd.	2001-07-17	67	0
K002140	MENICON PROGENT REMOVER	Menicon Co, Ltd.	2000-10-10	85	0
K000975	LIPIDURE REWETTING DROPS	Nof Corp.	2000-09-25	182	0
K001964	OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION	Lobob Laboratories, Inc.	2000-07-18	21	0
K001235	OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOS	Alcon Universal, Ltd.	2000-07-03	77	0
K001428	OPTIMUM WETTING AND REWETTING DROP	Lobob Laboratories, Inc.	2000-05-26	21	0
K000607	SOLO-CARE BRAND HARD SOLUTION	Ciba Vision Corporation	2000-05-15	82	0
K000385	OPTI-FREE EXPRESS LENS DROPS	Alcon Universal, Ltd.	2000-04-28	81	0
K000148	RGP MULTI-PURPOSE SOLUTION ID 100136	Alcon Laboratories	2000-04-11	84	0
K994170	HYLASHIELD CL	Biomatrix, Inc.	2000-03-02	83	0
K993949	SOLO-CARE BRAND HARD SOLUTION	Ciba Vision Corporation	2000-01-05	44	0
K983836	RIGID GAS PERMEABLE CONTACT LENS SOLUTION	Polymer Technology Div. Wilmington Partners, L.P.	1999-02-11	104	2
K983291	SOLO-CARE BRAND MULTI-PURPOSE SOLUTION	Ciba Vision Corporation	1998-11-25	65	0
K974466	BOSTON ADVANCE CLEANER	Polymer Technology Corp.	1998-02-19	85	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