510(k) Report

FDA applicant

Nytone Medical

Salt Lake City, UT1 decision1985–19850 recalls

FDA records 1 decision for Nytone Medical (Salt Lake City, UT) in 1985: 1 510(k) clearance. All are in product code KPN (Alarm, Conditioned Response Enuresis). 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 Nytone Medical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nytone Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nytone Medical 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?

  • KPNAlarm, Conditioned Response Enuresis1decision

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.

  • K844866Nytone Enuretic Alarm Bedwetting DeviceNytone Medical · 19851cites it

What has FDA decided for it lately?

  • K844866Nytone Enuretic Alarm Bedwetting DeviceNytone Medical · 1985

The one decision as Nytone Medical →