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

FWF — Predicate Candidate Screening

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

78 daysmedian FDA review time

164 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days
K053412	FLEXISCOPE, MODELS 50MH AND 50 MHC	Schoelly Imaging, Inc.	2006-02-23	78
K990154	KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM	Karl Storz Imaging, Inc.	1999-06-01	133
K982754	EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P	A.Stein - Regulatory Affairs Consulting	1999-01-08	155
K982965	ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND AC	Richard Wolf Medical Instruments Corp.	1998-11-23	90
K982397	VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM	Angiolaz, Inc.	1998-09-10	63
K982409	VES 1501-M	Angiolaz, Inc.	1998-08-21	42
K981819	ANGIOLAZ VES-1CAM	Angiolaz, Inc.	1998-08-04	74
K944707	ISOLATED CAMERA HEAD	Envision Medical Corp.	1994-10-07	14
K930297	FUJINON VIDEO LAPAROSCOPE, MODIFIED	Fujinon, Inc.	1994-03-29	432
K934682	SURGICAL VIDEO CAMERA AND ACCESSORIES	Medical Dynamics, Inc.	1994-02-15	138
K932628	ENDOSCOPIC VIDEO CAMERA	Stephen Chakoff, Inc.	1993-10-15	136
K926166	COAST VIDEO ENDOSCOPIC IMAGING SYSTEM	Optik	1993-06-01	175
K930053	VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10	Medical Devices, Inc.	1993-05-17	131
K925108	INTEGRATED VISUALIZATION SYSTEM	Neuro Navigational Corp.	1993-01-29	112
K923160	3DSCOPE	American Surgical Technologies Corp.	1992-12-10	164
K911163	IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS	Imagyn Medical, Inc.	1991-06-03	80
K905393	HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR	Frigitronics, Inc.	1991-01-16	47
K881014	THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM	KARL STORZ Endoscopy-America, Inc.	1988-04-14	35
K872661	RGB CAMERA SYSTEM	Aspen Laboratories, Inc.	1987-07-21	14
K871056	MEDICAM S-4 SURGICAL CAMERA	M.P. Video, Inc.	1987-03-31	14
K863598	VIDEO CAMERA SYSTEM	American Edwards Laboratories	1986-10-02	17
K863376	MODEL MC-1 SURGICAL VIDEO CAMERA	Biometric Products, Inc.	1986-10-02	29
K834069	ARTHROSCAN VIDEO SYSTEM	Concept, Inc.	1984-01-27	63

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