510(k) Report

FDA applicant

Interacoustics A/S, Assens

Eden Prairie, MN4 decisions2002–20060 recalls

FDA records 4 decisions for Interacoustics A/S, Assens (Eden Prairie, MN) from 2002 to 2006: 4 510(k) clearances. Most are in product codes EWO (Audiometer) and ETY (Tester, Auditory Impedance). 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 Interacoustics A/S, Assens’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Interacoustics A/S, Assens since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Interacoustics A/S, Assens 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
  • ETYTester, Auditory Impedance1decision
  • ETWCalibrator, Hearing Aid / Earphone And Analysis Systems1decision

Who builds on its devices?

Later devices cite its devices 4 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.

  • K060539DPOAE20 , EclipseInteracoustics A/S, Assens · 20062cite it
  • K022728Audiotraveller, Model AA222Interacoustics A/S, Assens · 20021cites it
  • K030016TEOAE25Interacoustics A/S, Assens · 20031cites it

What has FDA decided for it lately?

  • K060539DPOAE20 , EclipseInteracoustics A/S, Assens · 2006
  • K050496REM440Interacoustics A/S, Assens · 2005
  • K030016TEOAE25Interacoustics A/S, Assens · 2003
  • K022728Audiotraveller, Model AA222Interacoustics A/S, Assens · 2002

All 4 as Interacoustics A/S, Assens →

Other applicant names beginning “Interacoustics”

FDA records each applicant name separately; these may or may not be the same firm.

Interacoustics A/S 17Interacoustics AS 4