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

GDO — Predicate Candidate Screening

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

29 daysmedian FDA review time

119 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K926199	UNICLIP SURGICAL CLIP APPLIER	Unisurge, Inc.	1993-04-20	132	0
K890941	MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP	United States Surgical, A Division of Tyco Healthc	1989-04-07	43	0
K890159	TOWEL CLIPS	Dhason Brothers, Inc.	1989-02-03	25	0
K890233	SUTURE CLIP APPLIER/REMOVER	Kinetic Medical Products	1989-01-27	9	0
K820837	DISPOSABLE MULTIPLE LIGATING CLIP	ETHICON, Inc.	1982-05-28	63	0
K812291	ETHICON MULTIPLE LIGATING CLIP APPLIER	ETHICON, Inc.	1981-09-11	29	3
K792378	HEMOSPENSER CARTRIDGE CAT. NO. 523500-	Edward Weck, Inc.	1979-12-06	10	0
K791845	BAYONET HEIFETZ CLIP APPLIERS	Edward Weck, Inc.	1979-10-17	28	0
K790855	SURGICAL DRAPE CLIP #201	C. Intl.	1979-08-03	91	0
K791157	360 HEMOCLIP APPLIERS	Edward Weck, Inc.	1979-06-27	6	0
K790990	REYNOLDS DOUBLE HEMOCLIP APPLIERS	Edward Weck, Inc.	1979-06-05	6	0
K772286	FORCEPS, SUTURE, AUTO	Hartmann Group, Inc.	1977-12-20	8	0
K771412	LIGACLIP MULTIPLE CLIP APPLIER	ETHICON, Inc.	1977-11-28	119	0
K771640	SUTURE CLIP REMOVER	United States Surgical, A Division of Tyco Healthc	1977-09-30	32	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