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

OTM — Predicate Candidate Screening

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

60 daysmedian FDA review time

109 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K242960	AdVance™ XP Male Sling System (720163-03)	Boston Scientific Corporation	2024-11-15	51	0
K231891	Virtue Male Sling System with Alexis Wound Retractor Conveni	Coloplast	2023-09-25	90	0
K211847	AdVance XP Male Sling System	Boston Scientific Corporation	2021-12-20	188	0
K182169	AdVance XP Male Sling	Boston Scientific Corporation	2018-11-27	109	0
K113496	VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVEN	Coloplast A/S	2012-02-14	81	0
K111881	VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT	Coloplast A/S	2011-08-17	47	0
K101297	VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020	Coloplast A/S	2010-06-03	24	0
K091152	VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020	Coloplast A/S	2009-05-07	17	0
K082640	VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM	Coloplast Manufacturing Us, LLC	2008-10-17	37	0
K063079	I-STOP TRANS OBTURATOR MALE SLING	Cl Medical	2006-11-07	28	0
K062341	MALE REMEEX SYSTEM	Specialities Remeex International, S.L.	2006-11-02	84	0
K053371	AMS MALE TRANSOBTURATOR SLING SYSTEM	American Medical Systems, Inc.	2006-02-03	60	3

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