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

DWX — Predicate Candidate Screening

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

114 daysmedian FDA review time

247 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K121415	MOLLRING MULTITASC	LeMaitre Vascular, Inc.	2012-09-05	117
K032105	ENDOHELIX ENDARTERECTOMY DEVICE	Endarx, Inc.	2003-10-30	114
K020925	CARBODISSECTING ENDOSCOPE	Endo Surgical Devices, Inc.	2003-04-29	404
K003719	VASCULAR ARCHITECTS PERISCOPE DEVICE	Vascular Architects, Inc.	2001-02-28	86
K950813	MOLLRING CUTTER	Cardio Vascular Concepts, Inc.	1995-07-25	153
K933498	EXTERNAL VEIN STRIPPER	Applied Medical Resources	1994-03-23	247
K913803	INTRALUMINAL ARTERY STRIPPER	Omni-Tract Surgical, Div. Minn. Scientific, Inc.	1992-04-24	242
K911099	MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE	Pilling Co.	1991-06-25	105
K904944	TRANSLUMINAL ENDARTERECTOMY DEVICE	Baxter Healthcare Corp	1990-12-17	46
K895878	OLYMPUS VALVULOTOME W/DETACHABLE TIP	Olympus Corp.	1990-01-02	89
K894496	OLYMPUS VALVULOTOME W/FIXED TIP	Olympus Corp.	1989-10-12	85
K890515	PERIPHERAL ATHERECTOMY SYSTEM	Intensive Technology, Inc.	1989-05-23	111
K841521	SCANLAN ENDARSECTOR	Scanlan Intl., Inc.	1984-08-03	113
K801063	HALL ARTERIAL OSCILLATOR	American Sterilizer Co.	1980-09-26	143

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