Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

MAL · Predicate Candidate Screening

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

92 daysmedian FDA review time

101 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K122612	HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M0020217	Maquet Cardiovascular, LLC	2012-09-10	14	0
K103080	ALBOGRAFT VASCULAR PROSTHESIS	LeMaitre Vascular, Inc.	2011-01-19	92	17
K093231	ALBOGRAFT VASCULAR PROSTHESIS	LeMaitre Vascular, Inc.	2010-01-14	92	17
K052302	HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURA	Boston Scientific Corp	2005-09-12	19	1
K021213	MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VE	Boston Scientific Corp	2002-04-19	2	1
K954848	HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT	Meadox Medicals, Div. Boston Scientific Corp.	1996-02-01	101	1

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