510(k) Report

FDA applicant

Gn Otometrics A/S

Schaumburg, IL6 decisions2004–20151 recall

FDA records 6 decisions for Gn Otometrics A/S (Schaumburg, IL) from 2004 to 2015: 6 510(k) clearances. Most are in product codes ETW (Calibrator, Hearing Aid / Earphone And…) and GWJ (Stimulator, Auditory, Evoked Response). Its devices cite 11 predicates, 2 of them its own earlier devices. 1 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 Gn Otometrics A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2009: 12011: 12015: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Gn Otometrics A/S 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?

  • ETWCalibrator, Hearing Aid / Earphone And Analysis Systems2decisions
  • GWJStimulator, Auditory, Evoked Response2decisions
  • ETYTester, Auditory Impedance1decision
  • GWNNystagmograph1decision

Whose devices does it build on?

Its devices cite 11 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 2 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.

  • K033645Otoflex 100 Tye 1012Gn Otometrics A/S · 20042cite it
  • K143670Ics Chartr EP 200 with VempGn Otometrics A/S · 20152cite it
  • K083399Ics Chartr EP 200Gn Otometrics A/S · 20091cites it
  • K061791Focus VNG/Eng Type 1068Gn Otometrics A/S · 20061cites it
  • K061104Speechlink 100 Type 1053Gn Otometrics A/S · 20061cites it

What has FDA decided for it lately?

  • K143670Ics Chartr EP 200 with VempGn Otometrics A/S · 2015
  • K110286GN Otometrics Type 1053 FreefitGn Otometrics A/S · 2011
  • K083399Ics Chartr EP 200Gn Otometrics A/S · 20091 recall
  • K061791Focus VNG/Eng Type 1068Gn Otometrics A/S · 2006
  • K061104Speechlink 100 Type 1053Gn Otometrics A/S · 2006
  • K033645Otoflex 100 Tye 1012Gn Otometrics A/S · 2004

All 6 as Gn Otometrics A/S →

What has been recalled?

1 recall linked to its devices; the latest:

  • K083399The ICS CHARTR EP 200May 28, 2019Class II