FDA applicant

Urometrics, Inc.

St. Paul, MN3 decisions1997–20000 recalls

FDA records 3 decisions for Urometrics, Inc. (St. Paul, MN) from 1997 to 2000: 2 510(k) clearances and 1 De Novo grant. Most are in product codes NBV (Device, Engorgement, Clitoral) and LIL (Monitor, Penile Tumescence). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Urometrics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Urometrics, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?