510(k) Report

FDA applicant

Monox, Inc.

Los Alamitos, CA1 decision1990–19900 recalls

FDA records 1 decision for Monox, Inc. (Los Alamitos, CA) in 1990: 1 510(k) clearance. All are in product code HGM (System, Monitoring, Perinatal). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Monox, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Monox, 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?

  • HGMSystem, Monitoring, Perinatal1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K893981WatchchildMonox, Inc. · 19902cite it

What has FDA decided for it lately?

  • K893981WatchchildMonox, Inc. · 1990

The one decision as Monox, Inc. →