Atlas FDA

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

Gramsmed, LLC — Predicate Candidate Screening

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

83 daysmedian FDA review time
167 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K021043GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMICGramsmed, LLC2002-06-21810
K010672MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTUREGramsmed, LLC2001-05-18730
K003017GRAMSORB SYNTHETIC ABSORBABLE SUTUREGramsmed, LLC2001-03-131670
K003590GRAMS POLYESTER NONABSORBABLE SUTUREGramsmed, LLC2001-03-051040
K003000GRAMS NYLON NONABSORBABLE SUTUREGramsmed, LLC2000-12-18830
K002999GRAMS POLYPROPYLENE NONABSORBABLE SUTUREGramsmed, LLC2000-12-18830
K003001GRAMS SILK NONABSORBABLE SUTUREGramsmed, LLC2000-12-15800

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