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

GAN — Predicate Candidate Screening

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

170 daysmedian FDA review time

715 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K003015	SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD	Surgical Specialties Corp	2000-12-15	79	0
K964072	MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED	ETHICON, Inc.	1996-12-18	68	2
K960653	MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)	ETHICON, Inc.	1996-03-28	42	2
K951231	ORTHOPEDIC PACKS	Sterile Concepts, Inc.	1995-12-01	256	0
K920978	ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED	ETHICON, Inc.	1994-02-15	715	0
K900198	DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.	American Cyanamid Co.	1990-07-05	170	0
K895579	POLYSORB SYNTHETIC ABSORBABLE SUTURE	United States Surgical, A Division of Tyco Healthc	1990-07-05	293	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