Atlas FDA

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

Sutures India Private Limited — Predicate Candidate Screening

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

360 daysmedian FDA review time
361 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K041511TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURESutures India Private Limited2005-06-033610
K041514TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURESutures India Private Limited2005-06-033610
K041510TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURESutures India Private Limited2005-06-023600
K041512NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURESutures India Private Limited2005-06-023600
K041515TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURESutures India Private Limited2005-04-083050

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