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

KYB — Predicate Candidate Screening

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

87 daysmedian FDA review time

241 days90th percentile

39clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K152357	MicroSTAAR Injector System Cartridges	STAAR Surgical Company	2015-10-30	71	0
K081382	DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786	Duckworth & Kent, Ltd.	2008-10-23	160	0
K072985	DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2	Duckworth & Kent, Ltd.	2008-06-20	241	0
K070669	IOL INJECTOR SET	Medicel AG	2007-11-01	234	1
K063155	MONARCH III IOL DELIVERY SYSTEM	Alcon Manufacturing, Ltd.	2007-03-27	161	1
K063694	AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28	Bausch & Lomb, Inc.	2007-03-07	84	0
K032412	RE-USEABLE MICROSTAAR INJECTOR, MSI-S	Staar Surgical Co.	2004-06-10	310	0
K022723	MASTEL 1 FOLDER IMPLANTATION SYSTEM	Mastel Precision, Inc.	2002-12-26	132	0
K001157	MONARCH II IOL DELIVERY SYSTEM	Alcon Research, Ltd.	2000-06-27	78	1
K983129	DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)	Staar Surgical Co.	1998-12-04	87	0
K981571	MONARCH IOL DELIVERY SYSTEM	Alcon Laboratories	1998-07-09	66	0
K970033	MONARCH IOL DELIVERY SYSTEM	Alcon Laboratories	1997-04-23	110	0
K965185	ACRYPAK FOLDER	Alcon Laboratories	1997-03-31	97	0
K961242	AMO PHACOFLEX II INTERSECTION SYSTEM	Allergan, Inc.	1996-06-17	77	0
K954600	MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)	Staar Surgical Co.	1995-12-21	87	0
K951292	PASSPORT FOLDABLE LENS PLACEMENT SYSTEM	Chiron Vision Corp.	1995-06-02	72	0
K930628	KLAAS IOL LENSFOLDER	Bova Intl.	1995-02-07	729	0
K940593	DISPOSABLE MICROSTAAR INJECTOR	Staar Sugical	1994-09-19	222	0
K941603	AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE	Allergan Medical Optics	1994-07-06	96	0
K930320	AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR	Allergan Medical Optics	1994-04-07	440	0
K903575	CHIROFLEX FORCEPS	Chiron Ophthalmics	1990-12-21	135	0
K903574	CHIROFLEX LENS MICROSERT	Chiron Ophthalmics	1990-09-17	40	0
K883489	KRATZ NOVA SERT(TM)	Coopervision-Cilco	1988-10-25	70	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
K861990	SOFT LENS FOLDER	Staar Surgical Co.	1986-06-17	25	0
K861085	ELASTIC LENS INJECTOR TM	Staar Surgical Co.	1986-05-28	68	0
K860148	MAZZOCCO/FRENCHIK FOLDER	Staar Surgical Co.	1986-03-21	65	0
K854994	BARTELL SMALL INCISION LENS GLIDE	Microtech, Inc.	1986-02-04	54	0
K854197	IOSERT LENS IMPLANT INSTRUMENT	Chiron Vision Corp.	1986-01-22	99	0
K841730	BAILEY LENS SHOOTER	Intermedics Intraocular, Inc.	1984-11-19	208	0
K840694	LENS INSERTION GLIDE	Innovative Surgical Products, Inc.	1984-05-09	83	0
K840104	PETRUS IOL GUIDE	Precision-Cosmet Co., Inc.	1984-04-24	105	0
K832939	I-GLIDE IOL IMPLANTATION AID	I For M, Inc.	1983-10-04	35	0
K823222	INTRAOCULAR LENS GUIDE	American Medical Optics	1982-12-28	60	0
K821381	IOL FORCEPS	Cilco, Inc.	1982-06-14	35	0
K811718	SURFACE REPLACEMENT HIP PROSTHESIS	Biomet, Inc.	1981-09-18	92	0
K792066	M.P.I. LENS GLIDE	J. Leon Bilby	1980-01-29	106	0
K791351	CEMENT SPACERS	Depuy, Inc.	1979-08-03	17	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