510(k) Report

FDA applicant

Medron, Inc.

Salt Lake City, UT3 decisions1994–20200 recalls

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, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Medron, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medron, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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