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

GDJ · Predicate Candidate Screening

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

35 daysmedian FDA review time

164 days90th percentile

32clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K153358	Standard Clamp	Standard Bariatrics	2016-05-02	164	0
K930315	THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCE	Thomasville Medical Assoc.	1994-02-04	378	0
K924223	MAR-MED LIVER STRAP	Mar-Med Co.	1993-03-18	209	0
K922659	GENERAL SURGERY CLAMP AND NEEDLE HOLDER	Miltex Instrument Co.	1992-07-21	48	0
K914913	GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST	Ideal Medical, Inc.	1991-12-31	60	0
K900956	GS-7100 CHOLANGIOGRAM CLAMP, 5MM	Solos Endoscopy, Inc.	1990-04-18	50	0
K901107	MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC	United States Surgical, A Division of Tyco Healthc	1990-04-09	32	0
K895726	VESSEL OCCLUDER	Applied Medical Technologies	1989-10-24	29	0
K895591	SILICONE INSTRUMENT SHODS	Key Surgical, Inc.	1989-10-20	35	0
K882169	SURGICAL DUCT CLAMP (VINE)	Henley Intl.	1988-06-17	24	0
K881741	STUART LEE CLIP	Stuart-Lee, Inc.	1988-06-03	42	0
K881084	UTILITY CLAMP	Med-Dex Intl.	1988-03-25	11	0
K874428	AUTO SUTURE PURSE STRING APPLIER*	United States Surgical, A Division of Tyco Healthc	1987-12-02	35	0
K855144	TOURIQUET KIT WITH SNARE	Dlp, Inc.	1986-02-05	41	1
K853583	MODERN MEDICAL PRODUCTS TOWEL CLAMP	Modern Medical Products	1985-09-16	21	0
K852724	BACKHAUS TOWEL CLAMP, 5-1/2 + SS 410 OR 420	The Huxley Instrument Corp.	1985-07-15	19	0
K851774	17-900 TO 17-980 VARIOUS TOWEL CLAMPS	Artiberia	1985-06-20	56	0
K843816	TAL-CLIP	Talboy, Inc.	1984-10-31	33	0
K812388	SURGICAL PAWS	Berkeley Medevices	1981-11-16	88	0
K801660	PROXIMATE * PSD PURSE-STRING DEVICE	ETHICON, Inc.	1980-08-13	23	0
K800074	VESSEL OCCLUDER	Cordis Corp.	1980-01-28	14	0
K791800	CONPHAR UMBILICAL CORD CLAMP	Conphar, Inc.	1979-09-21	8	0
K791802	CONPHAR TUBE CLAMPS	Conphar, Inc.	1979-09-21	8	0
K782006	MEDGENERAL SINGLE-USE BULLDOG	Med General	1978-12-15	14	0
K780721	IDENTI-CLAMPS	Berkeley Bio-Medical, Inc.	1978-10-17	169	0
K780290	ULNAR-RADIAL CLIP	Edward Weck, Inc.	1978-02-28	7	0
K780291	ULNAR-RADIAL APPROXIMATER	Edward Weck, Inc.	1978-02-28	7	0
K780288	BRACHEAL-LARGE VESSEL CLIP	Edward Weck, Inc.	1978-02-28	7	0
K780286	BRACHIAL-LARGE VESSEL APPROXIMATOR	Edward Weck, Inc.	1978-02-28	7	0
K771701	VESSEL-CLUDE	Med General	1977-12-13	96	0
K771589	AUTO SUTURE	U. S. Surgical Corp.	1977-12-13	116	0
K760898	GOLDFARB LIVER CLAMP	Edward Weck, Inc.	1976-12-29	64	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