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

American Silk Sutures, Inc. · Predicate Candidate Screening

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

42 daysmedian FDA review time

143 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K922143	AMERICAN BURN SHEET	American Silk Sutures, Inc.	1992-08-10	96	0
K904514	STRUNG TELFA NON-ADHERENT SPONGE	American Silk Sutures, Inc.	1991-03-27	176	0
K902921	RAYON NEUROLOGICAL SPONGE	American Silk Sutures, Inc.	1990-09-18	77	0
K872810	STRUNG DENTAL ROLLS	American Silk Sutures, Inc.	1987-12-04	143	0
K872951	AMERICAN BRAIN RETRACTOR COVER	American Silk Sutures, Inc.	1987-09-16	50	0
K872905	AMERICAN NASAL SPONGE	American Silk Sutures, Inc.	1987-09-04	42	0
K872906	SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE	American Silk Sutures, Inc.	1987-08-11	18	0
K872807	NON-WOVEN TRACHEOTOMY SPONGE	American Silk Sutures, Inc.	1987-08-04	21	0
K872809	GAUZE CHERRY SPONGE	American Silk Sutures, Inc.	1987-08-04	21	0
K872806	STICK SPONGE, STRUNG TONSIL SPONGE DOUBLE STRUNG	American Silk Sutures, Inc.	1987-08-04	21	0
K872808	CHEVRON TAPE DISSECTOR, 9/16 X 1/4, 9/16 X 1/8	American Silk Sutures, Inc.	1987-08-04	21	0
K862494	POLYESTER SPONGE PATTIE	American Silk Sutures, Inc.	1986-07-30	29	0
K854713	COTTON NEUROLOGICAL SPONGE	American Silk Sutures, Inc.	1986-03-20	118	0
K854714	X-RAY DETECTABLE COTTON BALLS	American Silk Sutures, Inc.	1985-12-17	25	1

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