Atlas FDA

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

Trireme Medical, Inc. — Predicate Candidate Screening

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

35 daysmedian FDA review time
188 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K133633CHOCOLATE PTCA BOLLOON CATHETERTrireme Medical, Inc.2014-06-021880
K130414CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WTrireme Medical, Inc.2013-06-151160
K122070CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WTrireme Medical, Inc.2012-08-15300
K121681GLIDER PTCA BALLOON CATHETERTrireme Medical, Inc.2012-06-26190
K121402CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WTrireme Medical, Inc.2012-06-08290
K120677CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.Trireme Medical, Inc.2012-03-1590
K111544GLIDER PTCA BALLOON CATHETERTrireme Medical, Inc.2012-03-022730
K111738CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0Trireme Medical, Inc.2011-12-141760
K112281GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDETrireme Medical, Inc.2011-08-1780
K103534GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014Trireme Medical, Inc.2011-01-05350
K101062GLIDER PTA BALLOON CATHETERTrireme Medical, Inc.2010-05-12260
K094019GLIDER PTA BALLOON CATHETERTrireme Medical, Inc.2010-02-12450

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