Atlas FDA

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

Lukens Medical Corp. — Predicate Candidate Screening

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

297 daysmedian FDA review time
297 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K965162LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICALukens Medical Corp.1997-02-12501
K930943LUKENS NYLON SURGICAL SUTURELukens Medical Corp.1993-12-172970
K930942LUKENS SILK SURGICAL SUTURELukens Medical Corp.1993-12-172970
K930944LUKENS SURGICAL GUT SUTURELukens Medical Corp.1993-12-172970
K930945BRAIDED POLYESTER SURGICAL SUTURELukens Medical Corp.1993-12-172970
K930941LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLELukens Medical Corp.1993-12-172970
K930940LUKENS STAINLESS STEEL SURGICAL SUTURELukens Medical Corp.1993-12-172970
K904535LU-TEX IILukens Medical Corp.1991-01-301180

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