510(k) Report

FDA applicant

Uro Pharmaceuticals, Inc.

Port Angeles, WA1 decision1985–19850 recalls

FDA records 1 decision for Uro Pharmaceuticals, Inc. (Port Angeles, WA) in 1985: 1 510(k) clearance. All are in product code LNW (Paper, Obstetric Ph). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Uro Pharmaceuticals, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LNWPaper, Obstetric Ph1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K850858OB-PH - PH Test PaperUro Pharmaceuticals, Inc. · 19851cites it

What has FDA decided for it lately?

  • K850858OB-PH - PH Test PaperUro Pharmaceuticals, Inc. · 1985

The one decision as Uro Pharmaceuticals, Inc. →