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

Tepha, Inc. — Predicate Candidate Screening

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

88 daysmedian FDA review time

272 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K233999	GalaFLEX LITE Scaffold	Tepha, Inc.	2024-04-09	113
K202425	SurgiLattice scaffold	Tepha, Inc.	2021-08-19	359
K211307	GalaSTITCH Absorbable Monofilament Suture	Tepha, Inc.	2021-05-27	28
K162922	GalaFORM 3D	Tepha, Inc.	2017-02-23	128
K161092	GalaSHAPE 3D	Tepha, Inc.	2016-08-23	127
K140533	GALAFLEX MESH	Tepha, Inc.	2014-05-21	78
K132348	TEPHAFLEX BRAIDED SUTURE	Tepha, Inc.	2013-09-05	38
K130326	TEPHAFLEX MELTBLOWN CONSTRUCT	Tepha, Inc.	2013-05-07	88
K113721	TEPHAFLEX LIGHT MESH	Tepha, Inc.	2012-02-15	58
K113723	TEPHAFLEX MESH	Tepha, Inc.	2012-02-15	58
K111946	TEPHAFLEX MESH	Tepha, Inc.	2011-09-26	80
K101287	TEPHAFLEX COMPOSITE MESH	Tepha, Inc.	2010-08-30	115
K091633	TEPHAFLEX SURGICAL FILM	Tepha, Inc.	2009-08-07	64
K082178	TEPHAFLEX ABSORBABLE SUTURE	Tepha, Inc.	2008-10-30	90
K081099	TEPHAFLEX ABSORBABLE SUTURE	Tepha, Inc.	2008-07-15	89
K072520	TEPHAFLEX SURGICAL FILM	Tepha, Inc.	2007-11-29	83
K070894	TEPHAFLEX SURGICAL MESH	Tepha, Inc.	2007-04-13	14
DEN060003	TEPHAFLEX ABSORBABLE SUTURE	Tepha, Inc.	2007-02-08	272

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