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

EQH — Predicate Candidate Screening

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

71 daysmedian FDA review time

250 days90th percentile

49clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K945876	WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT	Wells Johnson Co.	1995-12-04	368	0
K954184	JED-LIGHT FIBEROPTIC LIGHT SOURCE	Jedmed Instrument Co.	1995-11-13	68	0
K951829	COLD LIGHT SOURCE LOS 150	Laser-Optik-Systeme GmbH & Co. KG	1995-07-10	81	0
K932771	BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE	Xomed-Treace, Inc.	1994-08-24	442	0
K941661	GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT	Gm Engineering, Inc.	1994-08-23	140	0
K941662	GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT	Gm Engineering, Inc.	1994-07-20	106	0
K934911	SAPHIRE PLUS SURGICAL MIRROR	San Diego Swiss Machining, Inc.	1994-06-21	250	0
K932131	MID LABS TWIN ILLUMINATOR	Medical Instrument Development Laboratories, Inc.	1994-04-01	333	0
K930123	ASPIRATING ENDO OCULAR PROBE	Surgical Technologies, Inc.	1994-02-16	400	0
K933145	FIBEROPTIC LIGHTSOURCES AND CARRIERS	Electro Fiberoptics Corp.	1993-09-07	71	0
K923227	THROAT-A-SCOPE	Truphatek, Ltd.	1992-12-04	156	0
K923774	DISPOSABLE ENDOILLUMINATOR	O.R. Specialties, Inc.	1992-10-19	83	0
K922095	LX 150 LIGHT SOURCE	Welch Allyn, Inc.	1992-07-17	73	0
K914586	GRIESHABER THREE FUNCTION MANIPULATOR	Grieshaber & Co.	1992-01-03	79	0
K914585	GRIESHABER TWO FUNCTION MANIPULATOR	Grieshaber & Co.	1992-01-03	79	0
K914247	ASPIRATING ENDO OCULAR PROBE	Surgical Technologies, Inc.	1991-12-18	86	0
K912885	KAPS 90 DEGREE FIBEROPTIC ADAPTOR	Jedmed Instrument Co.	1991-08-30	60	0
K912767	FIBER OPTIC UNIVERAL CABLES, SCOPE ADAP., LT.SOURC	Microaire Advanced Surgical Products	1991-08-13	50	0
K912522	OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER	Summit Technology, Inc.	1991-07-25	64	0
K905437	RIVER MEDICAL MICRODRILL SYSTEM	River Medical, Inc.	1991-05-30	177	0
K904378	F.T.I. MEDICAL LIGHT GUIDE	Fiberoptics Technology, Inc.	1991-01-16	114	0
K904470	SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE	Summit Technology, Inc.	1990-12-24	84	0
K902784	FIBER OPTIC LIGHT SOURCE	Trek Medical Products, Inc.	1990-09-12	78	0
K896384	FIBEROPTIC LIGHT SOURCE, FOI-1A	Jedmed Instrument Co.	1990-01-23	78	0
K864387	LUXTEC FIBEROPTIC CABLES	Luxtec Corp.	1987-05-22	198	1
K864383	LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS	Luxtec Corp.	1987-01-14	70	0
K864382	FRAZIER SUCTION TUBE	Luxtec Corp.	1987-01-14	70	0
K854751	ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE	Aspen Laboratories, Inc.	1986-02-28	94	0
K841731	BRIMFIELD FIBEROPTIC LIGHT SCOURCE	Brimfield Scientific Instruments	1984-07-16	81	0
K831589	VENT TUBE FORCEPS	Treace Medical, Inc.	1983-06-16	30	0
K831590	T-TUBE INSERTER	Treace Medical, Inc.	1983-06-15	29	0
K823437	MCGEE 26GA. SUCTION TUBE	Treace Medical, Inc.	1982-12-09	23	0
K823436	MICROSURGICAL GAUGE	Treace Medical, Inc.	1982-12-09	23	0
K822259	LARYNGEAL SPATULAS	Kelleher Corp.	1982-10-22	85	0
K822282	FIBEROPTIC LIGHT CARRIERS	Kelleher Corp.	1982-08-30	32	0
K822175	ADAPTOR FOR FIBEROPTIC LIGHT SOURCE	Kelleher Corp.	1982-08-20	28	0
K822192	FIBEROPTIC LIGHT CARRIERS	Kelleher Corp.	1982-08-20	28	0
K820621	NASAL INSTRUMENTS	Applied Fiberoptics, Inc.	1982-03-19	11	0
K812429	DALE COMBO TRACHEOSTOMY TUBE HOLDER	Dale Medical Products, Inc.	1981-09-23	29	0
K802774	FIBER OPTIC ADAPTER #60-0892	Aspen Laboratories, Inc.	1980-12-16	43	0
K802772	FIBER OPTIC ADAPTER #60-0894	Aspen Laboratories, Inc.	1980-12-16	43	0
K802771	FIBER OPTIC ADAPTER #60-895	Aspen Laboratories, Inc.	1980-12-16	43	0
K802766	FIBER OPTIC ADAPTER CAT#60-0898	Aspen Laboratories, Inc.	1980-12-16	43	0
K802773	FIBER OPTIC LIGHT GUIDE #60-0767	Aspen Laboratories, Inc.	1980-12-16	43	0
K802767	FIBER OPTIC LIGHT GUIDE CAT#60-0768	Aspen Laboratories, Inc.	1980-12-16	43	0
K802768	FIBER OPTIC ADAPTER #60-0897	Aspen Laboratories, Inc.	1980-12-16	43	0
K802775	FIBER OPTIC ADAPTER #60-0896	Aspen Laboratories, Inc.	1980-12-16	43	0
K801176	FIBER OPTIC LIGHT SOURCE	Aspen Laboratories, Inc.	1980-05-28	12	0
K760653	ADAPTER/STANDARD FIBER OPTICS LIGHT	Pilling Co.	1976-12-06	81	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