Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

OTP — Predicate Candidate Screening

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

69 daysmedian FDA review time

164 days90th percentile

31clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K122459	PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE	Boston Scientific Corporation	2012-12-13	122	2
K121612	ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH	American Medical Systems	2012-07-20	49	0
K112842	AMS ELEVATE PC	American Medical Systems, Inc.	2011-10-25	26	0
K103426	LITE PELVIC FLOOR REPAIR KITS	Boston Scientific Corp	2011-09-14	296	0
K112386	EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM	Coloplast Corp.	2011-09-08	21	0
K102815	SURELIFT PROLAPSE SYSTEM	Neomedic International	2011-07-07	282	0
K111118	AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICA	American Medical Systems	2011-07-01	71	0
K092207	RESTORELLE POLYPROPYLENE MESH	Mpathy Medical Devices, Inc.	2009-08-04	13	0
K091131	PELVIC FLOOR REPAIR SYSTEM	Boston Scientific	2009-05-08	18	0
K083499	EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS	Coloplast A/S	2009-05-08	164	0
K090713	ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE-	American Medical Systems, Inc.	2009-04-02	15	0
K083722	ASCEND	Caldera Medical, Inc.	2009-03-31	106	0
K083839	AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTH	C.R. Bard, Inc.	2009-01-15	23	0
K082677	AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH IN	American Medical Systems, Inc.	2008-12-23	99	1
K082387	APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP,	American Medical Systems	2008-12-04	107	0
K082730	AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH	American Medical Systems, Inc.	2008-11-26	69	0
K081710	APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE	American Medical Systems	2008-10-15	120	0
K082571	AVAULTA SUPPORT SYSTEM	C.R. Bard, Inc.	2008-09-30	25	0
K081048	PINNACLE PELVIC FLOOR REPAIR KIT II	Boston Scientific Corp	2008-08-22	130	1
K071512	GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS	ETHICON, Inc.	2008-05-15	346	0
K080185	AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS EL	American Medical Systems, Inc.	2008-04-10	76	0
K072951	PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES	Sofradim Production	2007-12-19	62	0
K071957	PINNACLE PELVIC FLOOR REPAIR KITS	Boston Scientific Corp	2007-11-08	115	3
K063712	AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYS	C.R. Bard, Inc.	2007-03-12	88	0
K063562	GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS	ETHICON, Inc.	2007-02-26	91	0
K053414	MENTOR NOVASILK MESH	Mentor Corp.	2005-12-27	20	0
K051503	UGYTEX SUAL KNIT MESH	Sofradim Production	2005-08-05	59	0
K040623	AMS PERIGEE SYSTEM	American Medical Systems, Inc.	2004-05-17	69	0
K040537	AMS APOGEE VAULT SUSPENSION SYSTEM	American Medical Systems, Inc.	2004-04-22	51	0
K040521	MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH	American Medical Systems, Inc.	2004-03-24	23	0
K033636	AMS LARGE PORE POLYPROPYLENE MESH	American Medical Systems, Inc.	2003-12-31	42	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