Atlas FDA

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

Tissue Science Laboratories, Plc — Predicate Candidate Screening

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

184 daysmedian FDA review time
213 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K053562ZIMMER COLLAGEN REPAIR PATCHTissue Science Laboratories, Plc2006-06-231840
K050355PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANTTissue Science Laboratories, Plc2005-03-09230
K043366PERMACOL SURGICAL IMPLANTTissue Science Laboratories, Plc2004-12-1790
K021056PERMACOLTissue Science Laboratories, Plc2002-10-312130
K013625PERMACOLTissue Science Laboratories, Plc2002-01-17730
K992556PERMACOLTissue Science Laboratories, Plc2000-02-172020

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