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

NWB — Predicate Candidate Screening

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

122 daysmedian FDA review time

284 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K222020	HD-550 Video Endoscope System	Sonoscape Medical Corp.	2022-09-08	62	0
K211882	HD-550 Video Endoscope System	Sonoscape Medical Corp.	2022-04-01	284	0
K173921	HD-500 Video Endoscope System	Sonoscape Medical Corp.	2018-09-05	253	0
K133538	VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA C	Olympus Corporation of the Americas	2014-08-07	262	0
K100584	EVIS EXERAII 180 SYSTEM	Olympus Medical Systems Corporation	2010-07-02	122	7
K090980	HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, W	Olympus Winter & Ibe GmbH	2009-06-29	83	0
K072957	EVIS EXERA II 180 SYSTEM	Olympus Medical Systems Corporation	2008-03-18	151	0
K062049	EVIS EXERA II 180 SYSTEM	Olympus Medical Systems Corporation	2006-09-22	64	0
K051645	EVIS EXERA 160A SYSTEM	Olympus Medical Systems Corporation	2005-10-13	115	2

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