Atlas FDA

KZF

37 FDA 510(k) clearances · Product code

110 daysmedian time to decision
266 days90th percentile
37clearances measured

FDA profile

Official device name
Device, Medical Examination, Ac Powered
Device class
Class I (low risk)
Regulation
21 CFR 880.6320
Medical specialty
General Hospital
Adverse events (MAUDE)
2019: 27 · 2020: 47 · 2021: 21 · 2022: 70 · 2023: 83 · 2024: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
NEVOSCOPE (K954943)Nizar A. Mullani1996-03-27
WELCH ALLYN VIDEO EPISCOPE (K952835)Welch Allyn, Inc.1995-09-22
H 5100, H 5200, H 5300 (K945507)Rudolf Riester GmbH & Co. KG1994-12-09
SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG (K941869)The Lighthouse For the Blind, Inc.1994-08-03
WAVE FLUORESCENT MAGNIFIER (K936088)Burton Medical Products Corp.1994-04-26
MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION (K940284)Meddev International Corp.1994-02-28
SKYTRON EXAM LIGHT (K933564)Skytron, Div. the Kmw Group, Inc.1994-02-10
CHROMOPHARE (K935832)Berchtold Holding GmbH1994-02-03
AC-POWERED MEDICAL EXAMINATION LIGHT (K934259)Welch Allyn, Inc.1994-01-28
RITTER MODEL 158 AND 159 EXAM LIGHTS (K932719)Midmark Corp.1993-12-02
VITAPEN (K924447)Vitajet Corp.1993-09-27
MEDDEV MULTARRAY (TM) MEDICAL EXAMINATION LIGHT (K931197)Meddev International Corp.1993-09-23
HALUX TASKLIGHT (K931645)Burton Medical Products Corp.1993-08-20
MI-4 VARIABLE SPOT LIGHT (K931646)Medical Illumination, Inc.1993-08-19
MI-5 DIAGNOSTIC LIGHT (K931026)Medical Illumination, Inc.1993-08-19
M.E.D. LIGHT (K925710)Medical Illumination, Inc.1993-06-04
ILLUMINATOR III (K922278)Medical Illumination, Inc.1993-03-04
ILLUMINATOR VIII ULTRA/SPOT (K922282)Medical Illumination, Inc.1993-03-04
ILLUMINATOR VII MINI/LUM LIGHT (K922280)Medical Illumination, Inc.1993-02-05
ILLUMINATOR VII MINI/SPOT LIGHT (K922281)Medical Illumination, Inc.1993-02-05
ILLUMINATOR II (K922277)Medical Illumination, Inc.1993-02-05
LS100 HALOGEN EXAMINATION LIGHT, MODEL NO: 44100 (K921493)Welch Allyn, Inc.1992-11-03
EXAMINATION LAMP (K922150)Air-Shields, Inc.1992-07-21
EPISCOPE, MODEL 47300 (K920103)Welch Allyn, Inc.1992-04-28
LIGHT, HEAD, EXAMINATION (K901706)Burton Medical Products Corp.1990-07-19
OLYMPIC LIGHT-WARM (K896611)Olympic Medical Corp.1990-02-06
TINY HALOGEN EXAM LIGHT (K896962)Jedmed Instrument Co.1989-12-29
MODEL 0450000, OPAL MEDICAL EXAM LIGHT (K893808)Burton Medical Products Corp.1989-08-15
MODEL 0183010, PEARL MEDICAL EXAM LIGHT (K893807)Burton Medical Products Corp.1989-08-15
BASIC LIGHT (K861289)Burton Medical Products Corp.1986-04-18
WELCH ALLYN #48100 TASK LITE W/ACCESSORIES AS LIST (K852949)Welch Allyn, Inc.1985-09-04
MEDICAL EXAMINATION LIGHTS (K851742)Burton Medical Products Corp.1985-05-13
HI-LO FLOOR STANDING EXAM. LIGHT (K842135)Good-Lite Co.1984-07-06
LIC 180 MEDICAL LAMPS (K812142)Lada Intl., Inc.1981-08-13
VITA LAMP, MODEL 0350 (K800067)Tensor Industries, Inc.1980-05-08
ABCO EXAMINATION LAMP (GOOSENECK TYPE) (K800230)Abco Dealers, Inc.1980-02-26
HALOGEN EXAM. LITE #48400 (K780628)Welch Allyn, Inc.1978-06-06

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Every clearance here is in the API, with alerts when new ones post.