FDA applicant
Trireme Medical, Inc.
FDA records 15 decisions for Trireme Medical, Inc. (Pleasonton, CA) from 2010 to 2022: 14 510(k) clearances and 1 original PMA approval. Most are in product codes LOX (Catheters, Transluminal Coronary Angioplasty…) and LIT (Catheter, Angioplasty, Peripheral, Transluminal). Its devices cite 52 predicates, 31 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Trireme Medical, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Trireme Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Trireme Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report