Atlas FDA

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

Aptis Medical, LLC · Predicate Candidate Screening

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

56 daysmedian FDA review time
335 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K190599Aptis Medical Distal Radio Ulnar Joint ImplantAptis Medical, LLC2019-05-03560
K142569Aptis Medical Distal Radio Ulnar Joint ImplantAptis Medical, LLC2015-04-032030
K082839DISTAL RADIO-ULNAR JOINT IMPLANTAptis Medical, LLC2008-10-24280
K053119DISTAL RADIO-ULNAR JOINT IMPLANTAptis Medical, LLC2005-12-07300
K040497DISTAL RADIO-ULNAR JOINT IMPLANTAptis Medical, LLC2005-01-263350

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