510(k) Report

FDA applicant

Uroan Xxi Electromedicina

Baleares, ES1 decision2000–20000 recalls

FDA records 1 decision for Uroan Xxi Electromedicina (Baleares, ES) in 2000: 1 510(k) clearance. All are in product code LIL (Monitor, Penile Tumescence). No recall is linked to its devices.

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

How often FDA has decided Uroan Xxi Electromedicina’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Uroan Xxi Electromedicina since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Uroan Xxi Electromedicina 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?

  • LILMonitor, Penile Tumescence1decision

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.

  • K000194Digital Inflection Rigidometer (Dir)Uroan Xxi Electromedicina · 20001cites it

What has FDA decided for it lately?

  • K000194Digital Inflection Rigidometer (Dir)Uroan Xxi Electromedicina · 2000

The one decision as Uroan Xxi Electromedicina →

Other applicant names beginning “Uroan”

FDA records each applicant name separately; these may or may not be the same firm.

Uroan 21 1