510(k) Report

FDA applicant

Kedly, Inc.

St. Louis, MO2 decisions2000–20000 recalls

FDA records 2 decisions for Kedly, Inc. (St. Louis, MO) in 2000: 2 510(k) clearances. All are in product code EWO (Audiometer). 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

No FDA decision for Kedly, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Kedly, 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?

  • EWOAudiometer2decisions

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.

  • K001058Audioscreener Oae + AbrKedly, Inc. · 20001cites it

What has FDA decided for it lately?

  • K001058Audioscreener Oae + AbrKedly, Inc. · 2000
  • K000184Audioscreener OaeKedly, Inc. · 2000

All 2 as Kedly, Inc. →