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

KZF — Predicate Candidate Screening

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

110 daysmedian FDA review time

266 days90th percentile

37clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K954943	NEVOSCOPE	Nizar A. Mullani	1996-03-27	149	0
K952835	WELCH ALLYN VIDEO EPISCOPE	Welch Allyn, Inc.	1995-09-22	94	0
K945507	H 5100, H 5200, H 5300	Rudolf Riester GmbH & Co. KG	1994-12-09	30	0
K941869	SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG	The Lighthouse For the Blind, Inc.	1994-08-03	107	0
K936088	WAVE FLUORESCENT MAGNIFIER	Burton Medical Products Corp.	1994-04-26	126	0
K940284	MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION	Meddev International Corp.	1994-02-28	55	0
K933564	SKYTRON EXAM LIGHT	Skytron, Div. the Kmw Group, Inc.	1994-02-10	203	0
K935832	CHROMOPHARE	Berchtold Holding GmbH	1994-02-03	58	0
K934259	AC-POWERED MEDICAL EXAMINATION LIGHT	Welch Allyn, Inc.	1994-01-28	150	0
K932719	RITTER MODEL 158 AND 159 EXAM LIGHTS	Midmark Corp.	1993-12-02	181	0
K924447	VITAPEN	Vitajet Corp.	1993-09-27	391	0
K931197	MEDDEV MULTARRAY (TM) MEDICAL EXAMINATION LIGHT	Meddev International Corp.	1993-09-23	198	0
K931645	HALUX TASKLIGHT	Burton Medical Products Corp.	1993-08-20	140	0
K931646	MI-4 VARIABLE SPOT LIGHT	Medical Illumination, Inc.	1993-08-19	139	0
K931026	MI-5 DIAGNOSTIC LIGHT	Medical Illumination, Inc.	1993-08-19	171	0
K925710	M.E.D. LIGHT	Medical Illumination, Inc.	1993-06-04	204	0
K922278	ILLUMINATOR III	Medical Illumination, Inc.	1993-03-04	293	0
K922282	ILLUMINATOR VIII ULTRA/SPOT	Medical Illumination, Inc.	1993-03-04	293	0
K922280	ILLUMINATOR VII MINI/LUM LIGHT	Medical Illumination, Inc.	1993-02-05	266	0
K922281	ILLUMINATOR VII MINI/SPOT LIGHT	Medical Illumination, Inc.	1993-02-05	266	0
K922277	ILLUMINATOR II	Medical Illumination, Inc.	1993-02-05	266	0
K921493	LS100 HALOGEN EXAMINATION LIGHT, MODEL NO: 44100	Welch Allyn, Inc.	1992-11-03	218	0
K922150	EXAMINATION LAMP	Air-Shields, Inc.	1992-07-21	75	0
K920103	EPISCOPE, MODEL 47300	Welch Allyn, Inc.	1992-04-28	110	0
K901706	LIGHT, HEAD, EXAMINATION	Burton Medical Products Corp.	1990-07-19	98	0
K896611	OLYMPIC LIGHT-WARM	Olympic Medical Corp.	1990-02-06	77	0
K896962	TINY HALOGEN EXAM LIGHT	Jedmed Instrument Co.	1989-12-29	14	0
K893808	MODEL 0450000, OPAL MEDICAL EXAM LIGHT	Burton Medical Products Corp.	1989-08-15	85	0
K893807	MODEL 0183010, PEARL MEDICAL EXAM LIGHT	Burton Medical Products Corp.	1989-08-15	85	0
K861289	BASIC LIGHT	Burton Medical Products Corp.	1986-04-18	11	0
K852949	WELCH ALLYN #48100 TASK LITE W/ACCESSORIES AS LIST	Welch Allyn, Inc.	1985-09-04	55	0
K851742	MEDICAL EXAMINATION LIGHTS	Burton Medical Products Corp.	1985-05-13	14	1
K842135	HI-LO FLOOR STANDING EXAM. LIGHT	Good-Lite Co.	1984-07-06	37	0
K812142	LIC 180 MEDICAL LAMPS	Lada Intl., Inc.	1981-08-13	16	0
K800067	VITA LAMP, MODEL 0350	Tensor Industries, Inc.	1980-05-08	118	0
K800230	ABCO EXAMINATION LAMP (GOOSENECK TYPE)	Abco Dealers, Inc.	1980-02-26	21	0
K780628	HALOGEN EXAM. LITE #48400	Welch Allyn, Inc.	1978-06-06	50	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