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Alcon Laboratories — Predicate Candidate Screening

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

84 daysmedian FDA review time

319 days90th percentile

47clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K062624	NEXT GENERATION LASER	Alcon Laboratories	2007-11-05	426	0
K062865	SMALL VOLUME SYRINGE	Alcon Laboratories	2007-08-23	332	0
K000148	RGP MULTI-PURPOSE SOLUTION ID 100136	Alcon Laboratories	2000-04-11	84	0
K984573	OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP	Alcon Laboratories	1999-09-16	267	0
K990480	OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER	Alcon Laboratories	1999-05-10	83	0
K984575	MULTI-PURPOSE DISINFECTING SOLUTION ID 90746	Alcon Laboratories	1999-01-14	22	0
K983973	OPTI-ONE MULTI-PURPOSE SOLUTION	Alcon Laboratories	1998-12-18	39	0
K983780	MULTI-PURPOSE DISINFECTING SOLUTION ID 90746	Alcon Laboratories	1998-12-18	52	0
K981561	LIQUID ENZYME ID 90133	Alcon Laboratories	1998-07-24	84	0
K981571	MONARCH IOL DELIVERY SYSTEM	Alcon Laboratories	1998-07-09	66	0
K981103	TURBOSONICS LIMITED REUSE ULTRASONIC TIP	Alcon Laboratories	1998-06-23	89	0
K981151	OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER/ALCON WETTING, SO	Alcon Laboratories	1998-06-22	84	0
K980292	CATARACT LIQUEFRACTURE DEVICE	Alcon Laboratories	1998-05-19	113	0
K974625	OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER	Alcon Laboratories	1998-03-04	83	0
K974624	ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746	Alcon Laboratories	1998-03-04	83	0
K974281	ALCON CONTACT LENS CASE	Alcon Laboratories	1998-01-20	67	0
K973332	ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746	Alcon Laboratories	1997-12-02	89	0
K971618	ALCON CONTACT LENS CASE	Alcon Laboratories	1997-07-14	73	0
K970033	MONARCH IOL DELIVERY SYSTEM	Alcon Laboratories	1997-04-23	110	0
K965185	ACRYPAK FOLDER	Alcon Laboratories	1997-03-31	97	0
K962592	OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LAS	Alcon Laboratories	1996-09-23	83	0
K955789	ALCON SERIES 20000 LEGACY MACKOOL SYSTEM	Alcon Laboratories	1996-03-21	90	0
K952213	ALCON SERIES 20000 LEGACY PHACOEMULSIFIER	Alcon Laboratories	1995-08-09	90	0
K932062	OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR	Alcon Laboratories	1994-03-18	323	0
K930517	NON-ABSORBABLE SURGICAL SUTURES	Alcon Laboratories	1993-12-17	319	0
K931620	OPTI-FREE CONTACT LENS CASE	Alcon Laboratories	1993-06-28	87	0
K914334	ALCON(R) FX2(TM) PHOTOCOAGULATOR	Alcon Laboratories	1992-11-13	413	0
K920641	ALCON OPERATING MICROSCOPES	Alcon Laboratories	1992-10-09	240	0
K911587	K-SOL(TM)	Alcon Laboratories	1991-11-01	206	0
K912130	TBD KERATOSCOPE	Alcon Laboratories	1991-08-09	87	0
K912134	TBD, LENS MEASURING DEVICE	Alcon Laboratories	1991-07-25	72	0
K911808	GEMINI OPHTHALMIC SURGERY SYSTEM	Alcon Laboratories	1991-06-25	63	2
K895434	ALCON FOLDING FORCEPS	Alcon Laboratories	1989-12-04	87	0
K896004	ALCON SURGICAL SPONGE	Alcon Laboratories	1989-11-02	20	0
K885230	MCDONALD FOLDING FORCEPS	Alcon Laboratories	1989-05-17	148	0
K890303	OPTI-TEARS(R)	Alcon Laboratories	1989-02-17	25	0
K882723	ALCON FLUID INJECTOR	Alcon Laboratories	1988-11-08	130	0
K881682	ALCON SITE(R)-COMPATIBLE CASSETTE	Alcon Laboratories	1988-07-01	73	0
K880961	ALCON SURGICAL PROCEDURE PACKS	Alcon Laboratories	1988-04-29	52	12
K873548	OPTI-ZYME(R)	Alcon Laboratories	1987-09-29	29	0
K873099	MANUAL OPHTHALMIC SURGICAL INSTRUMENTS	Alcon Laboratories	1987-09-04	28	0
K854159	ELLIPTI-PUNCH	Alcon Laboratories	1985-11-15	35	0
K822104	ALCON INDIRECT OPHTHALMOSCOPE	Alcon Laboratories	1982-08-10	22	0
K812172	CONTACT LENS CLEANER	Alcon Laboratories	1981-08-31	32	0
K760696	REMOTE CONTROL SYSTEM FOR MICROSCOPE	Alcon Laboratories	1976-12-16	85	0
K760697	EVANS ARM AND HAND REST	Alcon Laboratories	1976-11-02	41	0
K760158	NEEDLES AND SUTURES, SILK & NYLON	Alcon Laboratories	1976-08-19	48	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