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

PAG — Predicate Candidate Screening

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

40 daysmedian FDA review time

116 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K090688	COOK UROLOGICAL GRAFT	Cook Biotech, Inc.	2009-07-10	116	0
K050445	AMS COLLAGEN DERMAL MATRIX	American Medical Systems, Inc.	2005-06-17	115	1
K042949	PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILA	C.R. Bard, Inc.	2004-11-09	14	0
K031295	BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM	C.R. Bard, Inc.	2003-05-15	22	0
K030460	MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX	Brennen Medical, Inc.	2003-03-07	23	0
K020654	STRATASIS SLING KIT	Cook Biotech, Inc.	2002-04-09	40	0
K993459	MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX	Advanced Uroscience, Inc.	1999-11-05	23	0
K992159	SURGISIS SLING	Cook Biotech, Inc.	1999-09-23	90	0
K982403	BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX	Brennen Medical, Inc.	1998-09-22	74	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