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

Endo Technic Corp. — Predicate Candidate Screening

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

143 daysmedian FDA review time

686 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K990908	MILLENNIUM	Endo Technic Corp.	1999-05-27	70	0
K971459	DERMALASE	Endo Technic Corp.	1997-07-18	88	0
K925079	LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER)	Endo Technic Corp.	1994-08-24	686	2
K930756	LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE	Endo Technic Corp.	1994-03-09	390	0
K925114	LAPAROSCOPIC INSTRUMENTS	Endo Technic Corp.	1994-02-28	507	0
K924058	TROCAR	Endo Technic Corp.	1993-03-30	230	0
K914825	1-125 ENDOSEED	Endo Technic Corp.	1992-03-19	143	0
K910200	LASER-35	Endo Technic Corp.	1991-05-09	114	0
K864976	SOLUSET CALCIUM DEMINERALIZING SOLUTION	Endo Technic Corp.	1987-02-27	70	0
K862129	SET CANAL SEALER PASTE	Endo Technic Corp.	1986-07-22	48	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