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

DWQ — Predicate Candidate Screening

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

129 daysmedian FDA review time

450 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K212894	PhasTIPP	LeMaitre Vascular, Inc.	2022-03-31	202	0
K041453	SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 72	Smith & Nephew, Inc.	2004-07-22	51	1
K032387	TRIVEX SYSTEM	Smith & Nephew, Inc.	2003-10-29	86	1
K905528	URESIL VALVE CUTTER	Uresil Corp.	1991-04-18	129	0
K904507	PILLING BRUSH VALVULOTOME	Pilling Co.	1991-03-01	150	0
K885046	INSITUCAT VALVE STRIPPER	Aesculap Instruments Corp.	1990-02-28	450	0
K872157	HALL VEIN STRIPPER	Solco Basle, Inc.	1987-07-07	33	0
K811910	VEIN-TRAP TM	Atrium Medical Corp.	1981-07-20	19	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