Atlas FDA

KQM

18 FDA 510(k) clearances · Product code

32 daysmedian time to decision
113 days90th percentile
18clearances measured

FDA profile

Official device name
Camera, Surgical And Accessories
Device class
Class I (low risk)
Regulation
21 CFR 878.4160
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2001: 4 · 2006: 3 · 2016: 11 · 2020: 19 · 2024: 29 · 2026: 523
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
ADAPTOR: KAPS CINE TO MOELLER BEAMSPLITTER (K900160)Jedmed Instrument Co.1990-01-24
SONY VIDEO GRAPHIC PRINTER UP-850 (K890826)Sony Corp. of America1989-03-14
SONY TRINITRON COLOR VIDEO MONITOR PVM-1343MD (K885042)Sony Medical Electronics Co.1988-12-22
SONY VIDEO PRINTERS, UP SERIES (K882958)Sony Medical Electronics Co.1988-08-04
MEDICAM MC-7 AND RP-7 SURGICAL CAMERAS (K882924)M.P. Video, Inc.1988-07-26
VIDEO PRINTER SYSTEM (K873419)Technology For Imaging, Inc.1987-11-02
SURGICAL CAMERA ACCESSORIES (K871595)M.P. Video, Inc.1987-05-07
ENDOSCOPIC VIDEO CAMERA (K863800)Technology For Imaging, Inc.1986-10-14
VIDEO PRINTER, MODEL 3200 (K860904)Medline Industries, Inc.1986-03-28
CONCEPT VIDEO IMAGING SYSTEM (K850749)Concept, Inc.1985-05-20
VIS-1000 VIDEO SYSTEM (K843806)Vistek Corp.1984-12-12
MED. DYNAMICS HIGH RESOLUTION SOLID ST (K843295)Medline Industries, Inc.1984-12-12
MED. DYNAMICS SATICAN VIDEO CAMERA 5410 (K843294)Medline Industries, Inc.1984-12-12
ENDOSCOPIC CAMERA TV W/AUDIO (K832342)Kamiya Tsusan Kaisha, Ltd.1983-09-12
OPTI-DISC (K820626)Video-Medical Devices, Ltd.1982-04-09
STERILE TV CAMERA & CORD COVER (K812405)Hydro-Med Products, Inc.1981-10-20
GATOR DRAPES (K811717)The Anspach Effort, Inc.1981-07-20
MEDISEAL CAMERA COVERS (K810512)Janin Group, Inc.1981-03-13

Track KQM automatically

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