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

Epimed International, Inc. — Predicate Candidate Screening

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

106 daysmedian FDA review time

212 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K200624	Percutaneous Introducer	Epimed International, Inc.	2020-04-27	48	0
K190256	Rulo Radiofrequency Lesion Probe	Epimed International, Inc.	2019-03-08	29	0
K133316	SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODE	Epimed International, Inc.	2014-05-28	212	0
K053318	RX EPIDURAL NEEDLE	Epimed International, Inc.	2006-02-17	79	0
K051171	STINGRAY EPIDURAL CATHETER CONNECTOR	Epimed International, Inc.	2005-08-26	112	1
K051860	FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837	Epimed International, Inc.	2005-08-22	45	0
K043467	FLEXIBLE SPINAL NEEDLE	Epimed International, Inc.	2005-03-31	106	0
K041021	RF INTRODUCTION CANNULA	Epimed International, Inc.	2004-09-16	149	2
K041843	PENCIL POINT NEEDLE	Epimed International, Inc.	2004-08-24	47	0
K023140	VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124	Epimed International, Inc.	2003-08-15	329	0
K030562	TUOHY EPIDURAL NEEDLE	Epimed International, Inc.	2003-04-03	41	0
K022029	QUINCKE SPINAL NEEDLE	Epimed International, Inc.	2002-07-30	39	0
K020926	EXTENSION SET, MODELS 1911-512	Epimed International, Inc.	2002-07-12	113	0
K981329	FETH-R-KATH	Epimed International, Inc.	1998-08-26	135	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