510(k) Report

FDA applicant

Urotec Systems Corp.

Pittsburgh, PA2 decisions1985–19860 recalls

FDA records 2 decisions for Urotec Systems Corp. (Pittsburgh, PA) from 1985 to 1986: 2 510(k) clearances. All are in product code KOD (Catheter, Urological). 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 Urotec Systems Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Urotec Systems Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Urotec Systems Corp. 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?

  • KODCatheter, Urological2decisions

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.

  • K851684Urotec/Franklin Soft Simplastic CatheterUrotec Systems Corp. · 19851cites it

What has FDA decided for it lately?

  • K854625Urotec Closed Irrigatiion SyringeUrotec Systems Corp. · 1986
  • K851684Urotec/Franklin Soft Simplastic CatheterUrotec Systems Corp. · 1985

All 2 as Urotec Systems Corp. →