510(k) Report

FDA applicant

Calmed Technology, Inc.

Union City, CA3 decisions1994–19950 recalls

FDA records 3 decisions for Calmed Technology, Inc. (Union City, CA) from 1994 to 1995: 3 510(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 Calmed Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Calmed Technology, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Calmed Technology, 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?

  • EWOAudiometer3decisions

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.

  • K940999Prodigit 2000Calmed Technology, Inc. · 19942cite it

What has FDA decided for it lately?

  • K950888Screening Audiometry Word Recognition AudiometryCalmed Technology, Inc. · 1995
  • K945689Game Audiometery Word Identification Audiometry for Use with Prodigit (TM) 2000 Personal Digital Audiometer…Calmed Technology, Inc. · 1995
  • K940999Prodigit 2000Calmed Technology, Inc. · 1994

All 3 as Calmed Technology, Inc. →