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

GDG — Predicate Candidate Screening

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

32 daysmedian FDA review time

113 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K900069	MODIFIED PGL ABSORBABLE STAPLE*	United States Surgical, A Division of Tyco Healthc	1990-04-16	102	0
K891898	SKIN HOOKS, VARIOUS TYPES	Zinnanti Surgical Instruments, Inc.	1989-04-12	19	0
K864425	RAYLOR(TM) DISSECTING HOOK	Cedar Surgical, Inc.	1986-12-12	32	0
K843136	BRIMFIELD CANNULATED GRASPING HOOKS	Brimfield Scientific Instruments	1984-09-25	47	0
K841010	SURGICAL HOOKS, VARIOUS	Premier Dental Products Co.	1984-05-01	53	0
K812562	SURGICAL RETRACTOR & ELASTIC STAYS, DISP	Humboldt Products	1981-10-02	24	0
K791120	MIDDLE EAR PICKS, HOOKS CURETTES,	Xomed, Inc.	1979-07-10	25	0
K780289	NERVE APPROXIMATER	Edward Weck, Inc.	1978-06-14	113	0
K771190	ABRAMSON TRACHEA HOOK & RETRACTOR	Edward Weck, Inc.	1977-07-11	10	0
K771187	DERMAHOOK #382-805	Edward Weck, Inc.	1977-07-11	10	2

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