510(k) Report

FDA applicant

Amplus Corp.

Boulder, CO4 decisions1988–19900 recalls

FDA records 4 decisions for Amplus Corp. (Boulder, CO) from 1988 to 1990: 4 510(k) clearances. Most are in product codes EWO (Audiometer) and GWL (Amplifier, Physiological Signal). 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 Amplus Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Amplus Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Amplus 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?

  • EWOAudiometer2decisions
  • GWLAmplifier, Physiological Signal1decision
  • ETYTester, Auditory Impedance1decision

Who builds on its devices?

Later devices cite its devices 6 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.

  • K891988Amplaid A308 Clinical AudiometerAmplus Corp. · 19892cite it
  • K903066Amplaid 770 Admittance MeterAmplus Corp. · 19902cite it
  • K880059Amplaid 309 Clinical AudiometerAmplus Corp. · 19882cite it

What has FDA decided for it lately?

  • K903066Amplaid 770 Admittance MeterAmplus Corp. · 1990
  • K891988Amplaid A308 Clinical AudiometerAmplus Corp. · 1989
  • K884071Amplaid EMG15Amplus Corp. · 1989
  • K880059Amplaid 309 Clinical AudiometerAmplus Corp. · 1988

All 4 as Amplus Corp. →