Atlas FDA

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

Demetech Corp. — Predicate Candidate Screening

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

197 daysmedian FDA review time
533 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K141007DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTUREDemetech Corp.2014-09-251600
K123940DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTUREDemetech Corp.2014-05-305260
K130083DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCLDemetech Corp.2013-07-171840
K082097DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABDemetech Corp.2010-01-085330
K072930DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUTDemetech Corp.2008-04-301970
K043330POLYPROPILENE SURGICAL SUTURESDemetech Corp.2005-05-161650
K043539DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDDemetech Corp.2005-04-061050
K023028DEMETECH NYLON NONABSORBABLE SUTUREDemetech Corp.2003-06-182800
K023030DEMETECH POLYESTER NONABSORBABLE SUTUREDemetech Corp.2003-06-182800
K023029DEMETECH SILK NONABSORBABLE SUTUREDemetech Corp.2002-11-25750

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