510(k) Report

FDA applicant

Micro Audiometrics Corp.

South Daytona, FL6 decisions1981–19980 recalls

FDA records 6 decisions for Micro Audiometrics Corp. (South Daytona, FL) from 1981 to 1998: 6 510(k) clearances. All are in product code EWO (Audiometer). Its devices cite 2 predicates, 1 of them its own earlier devices. 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 Micro Audiometrics Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Micro Audiometrics Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Micro Audiometrics Corp. 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?

  • EWOAudiometer6decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K982878Earscan 3Micro Audiometrics Corp. · 19981cites it
  • K812529EarscanMicro Audiometrics Corp. · 19811cites it

What has FDA decided for it lately?

  • K982878Earscan 3Micro Audiometrics Corp. · 1998
  • K924543DSP Screening AudiometerMicro Audiometrics Corp. · 1993
  • K913589Earscan DSP-1 Pure Tone AudiometerMicro Audiometrics Corp. · 1991
  • K904270Biolink Audiometer Software AccessoryMicro Audiometrics Corp. · 1990
  • K883505Biometer AudiometerMicro Audiometrics Corp. · 1989
  • K812529EarscanMicro Audiometrics Corp. · 1981

All 6 as Micro Audiometrics Corp. →