510(k) Report

FDA applicant

Etymotic Research

Elk Grove Village, IL11 decisions1984–20150 recalls

FDA records 11 decisions for Etymotic Research (Elk Grove Village, IL) from 1984 to 2015: 11 510(k) clearances. Most are in product codes EWO (Audiometer) and GXY (Electrode, Cutaneous). Its devices cite 9 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Etymotic Research, Inc.”.

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 Etymotic Research’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007: 12011: 12015: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Etymotic Research by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Etymotic Research’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • EWOAudiometer8decisions
  • GXYElectrode, Cutaneous1decision
  • ETWCalibrator, Hearing Aid / Earphone And Analysis Systems1decision
  • ESDHearing Aid, Air-Conduction, Prescription1decision

Whose devices does it build on?

Its devices cite 9 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 6 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.

  • K010165Ero Scan Oae Test SystemEtymotic Research · 20013cite it
  • K980533Ero-Scan Otoacoustic Emissions Test Inst. (ER34)Etymotic Research · 19982cite it
  • K930003Tubephone Models ER-3A & ER-3 Insert EarphonesEtymotic Research · 19932cite it
  • K930553Cub Dis Otoacoustic Emissions Test InstrumentEtymotic Research · 19931cites it
  • K150491ER36 Series OAE Test SystemEtymotic Research, Inc. · 20151cites it

What has FDA decided for it lately?

  • K150491ER36 Series OAE Test SystemEtymotic Research, Inc. · 2015
  • K112733ER35 Ero-Scan Pro Hearing Test SystemEtymotic Research, Inc. · 2011
  • K070880ER35 Ero-Scan Pro Hearing Test SystemEtymotic Research, Inc. · 2007
  • K011114Etymotic Research ER-10D Oae ProbeEtymotic Research · 2001
  • K010165Ero Scan Oae Test SystemEtymotic Research · 2001
  • K980533Ero-Scan Otoacoustic Emissions Test Inst. (ER34)Etymotic Research · 1998
  • K930553Cub Dis Otoacoustic Emissions Test InstrumentEtymotic Research · 1993
  • K930003Tubephone Models ER-3A & ER-3 Insert EarphonesEtymotic Research · 1993

All 8 as Etymotic Research →All 3 as Etymotic Research, Inc. →