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

Vascutek, Ltd. — Predicate Candidate Screening

26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

73 daysmedian FDA review time

269 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K241550	Gelweave™ Vascular Prostheses	Vascutek, Ltd.	2025-02-27	272	1
K241070	Gelsoft™ Plus Vascular Prostheses	Vascutek, Ltd.	2024-11-15	210	1
K202703	Vascutek Gelsoft Plus ERS Vascular Graft	Vascutek, Ltd.	2021-04-06	202	0
K200955	Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thi	Vascutek, Ltd.	2020-07-08	90	0
K162803	Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Pl	Vascutek, Ltd.	2017-07-14	282	0
K162794	Gelweave Vascular Grafts	Vascutek, Ltd.	2017-06-30	269	0
K093817	GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS	Vascutek, Ltd.	2010-01-07	27	0
K092863	MAXIFLO, TAPERFLO	Vascutek, Ltd.	2009-10-08	21	0
K091778	VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS	Vascutek, Ltd.	2009-08-31	75	0
K090987	VASCUTEK BRANCHED GELWEAVE	Vascutek, Ltd.	2009-06-19	73	0
K081560	VASCUTEK CANNULA GRAFT, MODEL CGS2008S	Vascutek, Ltd.	2009-02-10	252	0
K070323	TEMPORARY LIMB SALVAGE SHUNT	Vascutek, Ltd.	2007-02-15	13	0
K060142	VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RAD	Vascutek, Ltd.	2006-02-07	19	0
K043552	VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES	Vascutek, Ltd.	2005-01-05	9	0
K041528	MODIFICATION TO EPTFE GRAFT	Vascutek, Ltd.	2004-09-14	98	0
K040829	GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS W	Vascutek, Ltd.	2004-05-20	50	0
K034010	GELSOFT PLUS ERS	Vascutek, Ltd.	2004-02-19	57	0
K030999	EPTFE VASCULAR PROSTHESIS; SEALPTFE	Vascutek, Ltd.	2003-04-09	9	0
K964959	VASCUTEK TWILLWEAVE VASCULAR GRAFT	Vascutek, Ltd.	1997-03-10	89	0
K963611	VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCU	Vascutek, Ltd.	1996-11-21	72	0
K955230	VASCUTEK GELSOFT PLUS VASCULAR GRAFT	Vascutek, Ltd.	1996-02-09	87	0
K952293	VASCUTEK GELWEAVE VASCULAR GRAFT	Vascutek, Ltd.	1995-12-19	217	0
K910864	EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS	Vascutek, Ltd.	1991-04-01	31	0
K910865	TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS	Vascutek, Ltd.	1991-04-01	31	0
K910863	EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS	Vascutek, Ltd.	1991-04-01	31	0
K910866	VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS	Vascutek, Ltd.	1991-04-01	31	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