Atlas FDA

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

Advance Suture, Inc. — Predicate Candidate Screening

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

345 daysmedian FDA review time
373 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K903175ADVANCE SUTURE NONABSORBABLE DACRON SUTUREAdvance Suture, Inc.1991-07-263730
K903174ADVANCE SUTURE ABSORBABLE GUT SUTUREAdvance Suture, Inc.1991-07-103570
K903177ADVANCE SUTURE NONABSORBABLE NYLON SUTUREAdvance Suture, Inc.1991-06-283450
K903176ADVANCE SUTURE NONABSORBABLE POLYPROPYLENE SUTUREAdvance Suture, Inc.1991-06-283450
K905454ADVANCE SUTURE NONABSORBABLE SILK SUTUREAdvance Suture, Inc.1991-06-282050

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