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

KYG — Predicate Candidate Screening

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

76 daysmedian FDA review time

191 days90th percentile

40clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K010353	MED-LOGICS DISPOSABLE ALK TUBING	Med-Logics, Inc.	2001-04-27	80	0
K003036	TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE	Retinalabs.Com	2000-12-22	84	0
K993591	BLADEWORKS DISPOSABLE ALK TUBING	Blade Works, Inc.	1999-12-28	67	0
K981116	SOVEREIGN CATARACT EXTRACTION SYSTEM	Allergan, Inc.	1998-05-19	53	1
K980647	EYE IRRIGATOR MODEL #2020	Eye-Deal Ocular Safety Products, Inc.	1998-05-15	87	0
K974561	MOISTAIR FLUID AIR TUBING SET	American Medical Devices, Inc.	1998-02-19	76	0
K971173	ML DISPOSABLE ALK TUBING	Med-Logics, Inc.	1997-05-22	52	0
K970161	HEDGES CORNEAL WETTING PAK	Hedges Cwp, Inc.	1997-03-25	70	0
K954842	D.O.R.C. VFI/VFE SYSTEM	Dutch Ophthalmic USA, Inc.	1996-04-15	175	0
K945171	DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE	Boston Surgical Products, Inc.	1995-02-08	110	0
K940392	PEREGRINE PIC MINIPULATOR	Peregrine Surgical , Ltd.	1994-08-23	209	0
K935226	I/V POLE	Optical Micro Systems, Inc.	1994-02-16	107	0
K935003	ELECTRIC I/V POLE OR EIVP2	Optical Micro Systems, Inc.	1994-01-25	98	0
K925921	MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE	Site Microsurgical Systems, Inc.	1993-12-06	378	0
K924999	AUTOPOLE REGULATOR SYSTEM	Escalon Trek Medical	1992-12-24	83	0
K924052	INFINITY MICRO IRRIGATOR	Infinity Surgical Technology, Inc.	1992-12-23	133	0
K922996	MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS	Chiron Vision Corp.	1992-07-27	35	0
K922180	LEWICKY O.R.S. TUBING	O.R. Specialties, Inc.	1992-07-02	55	0
K915808	AQUEOUS PARACENTESIS PIPET	Visitec Co.	1992-03-19	86	0
K914587	GRIESHABER AIR/FLUID TUBING SET	Grieshaber & Co.	1992-01-23	99	0
K904186	SITE DIAPHRAGM CASSETTE	Site Microsurgical Systems, Inc.	1990-11-21	70	0
K881517	B & B I/A HANDPIECE	B&B Medical Assoc., Inc.	1988-08-22	133	0
K881518	INFUSION HANDLE	B&B Medical Assoc., Inc.	1988-08-22	133	0
K881682	ALCON SITE(R)-COMPATIBLE CASSETTE	Alcon Laboratories	1988-07-01	73	0
K880543	UNI-PORT	Surgeon Surgical Instrumentation, Inc.	1988-07-01	143	0
K871454	MORGAN THERAPEUTIC LENS	Mortan, Inc.	1987-06-19	67	0
K861203	MULTI-SPIKE	Surgeon Surgical Instrumentation, Inc.	1986-04-28	27	0
K860544	BACSTOP FILTER IRRIGATION SUPPLY KIT	Staar Surgical Co.	1986-04-04	50	0
K861013	ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)	Ameritek, Inc.	1986-03-31	13	0
K853243	VISITEC IRRIGATION CONTROL SYSTEM	Visitec Co.	1985-09-11	41	0
K845039	OPERAID DISPOS. IRRIGATING KNIFE	Jedmed Instrument Co.	1985-03-05	67	0
K841807	OPERAID NUCLEUS	Jedmed Instrument Co.	1984-11-21	204	0
K832787	ELECATH HEPARIN COATED THERMAL DILUTION	Electro-Catheter Corp.	1983-10-04	49	0
K831996	MICRO SURGICAL HANDLE	Visitec Co.	1983-07-12	21	0
K821897	LENS	Mortan, Inc.	1983-01-05	191	0
K820889	ASPIRATOR/IRRIGATOR OR I/A UNIT	Mid Laboratories, Inc.	1982-05-05	36	0
K820680	DISPOSABLE TUBING SETS	Innovative Surgical Products, Inc.	1982-04-09	29	0
K802332	INTRAJECT	General Medical Engineering Corp.	1980-12-22	90	0
K801822	NU-VISION DISP. OPHTHALMIC DRESSING TRAY	Summit Optics, Inc.	1980-09-30	61	0
K760820	NALGENE EMERGENCY EYE WASH	Nagle Co.	1976-10-20	7	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