FDA applicant

Urotronic, Inc.

Minneapolis4 decisions2020–20250 recalls

FDA records 4 decisions for Urotronic, Inc. (Minneapolis) from 2020 to 2025: 2 510(k) clearances and 2 original PMA approvals. Most are in product codes QRH (Catheter, Balloon, Urethral, Drug-Coated) and QXB (Drug Coated Prostatic Dilation Catheter For…). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2025

2020high 1 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Urotronic, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Urotronic, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?