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

DWP — Predicate Candidate Screening

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

89 daysmedian FDA review time

265 days90th percentile

20clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K220981	SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe	Fehling Surgical Instruments, Inc.	2023-04-20	381	0
K183438	Geomed Vascular Dilators	Geomed Medizin-Technik GmbH & Co.	2019-09-03	265	0
K163524	Vessel Dilator	Fetzer Medical GmbH & Co. KG	2017-06-29	196	0
K130896	VASCULAR PROBE, VASCULAR PROBE ES	Synovis Life Technologies, Inc.	2013-04-24	23	2
K100518	INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7	Instrumed International, Inc.	2010-08-31	189	0
K030788	KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY	Geister Medizin Technik GmbH	2003-07-12	122	0
K960312	RDI CARDIAC INSULATION PAD	R D Intl.	1996-04-19	88	0
K912548	LEMAITRE-BOOKWALTER VESSEL DEVICES	Vascutech, Inc.	1991-09-18	100	0
K911475	LAPAROSCOPIC VESSEL ARTICULATOR	United States Endoscopy Group, Inc.	1991-07-02	89	0
K910682	ROBICSEK PROBE/RETRACTOR	Bio-Vascular, Inc.	1991-05-08	78	0
K905159	FLO-RESTER(R) VESSEL SIZER	Bio-Vascular, Inc.	1991-02-07	83	0
K902143	FOGARTY VESSEL CALIBRATOR	Baxter Healthcare Corp	1990-10-16	154	0
K891786	PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE)	Pioneering Technologies, Inc.	1989-10-12	202	0
K833676	SURGICAL VESSEL DILATORS-CATHERIZA-	Cimed Intl., Inc.	1984-03-19	157	0
K832595	VESSEL DILATOR	Abbott Laboratories	1983-08-31	29	0
K822687	REUSABLE FOGARTY FLEXIBLE CALIBRATOR	American Edwards Laboratories	1982-10-04	31	0
K812935	FOGARTY FLEXIBLE PROBE	American Edwards Laboratories	1981-11-16	27	0
K810894	FOGARTY FLEXIBLE CALIBRATOR	American Edwards Laboratories	1981-05-15	42	0
K792134	BONCHEK-SHILEY VEIN DISTENTION SYSTEM	Shiley, Inc.	1979-12-04	43	0
K790938	SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO	Shiley, Inc.	1979-06-13	26	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