510(k) Report

FDA applicant

Numedtec, Inc.

Libertyville, IL2 decisions1990–19900 recalls

FDA records 2 decisions for Numedtec, Inc. (Libertyville, IL) in 1990: 2 510(k) clearances. All are in product code LKY (Device, External Penile Rigidity). 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 Numedtec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Numedtec, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Numedtec, 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?

  • LKYDevice, External Penile Rigidity2decisions

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.

  • K904485Support RingNumedtec, Inc. · 19901cites it

What has FDA decided for it lately?

  • K904485Support RingNumedtec, Inc. · 1990
  • K904486Support PumpNumedtec, Inc. · 1990

All 2 as Numedtec, Inc. →