FDA applicant
Medron, Inc.
FDA records 3 decisions for Medron, Inc. (Salt Lake City, UT) from 1994 to 2020: 3 510(k) clearances. Most are in product codes DRE (Dilator, Vessel, For Percutaneous…) and LFK (Catheter, Femoral). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Medron, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medron, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Medron, 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