510(k) · Cleared
ClearedGN Otometrics Insert Earphones
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gn Otometrics · EWO Audiometer
Cleared on Jul 14, 2008 as substantially equivalent to K930003 (Etymotic Research, 1993) after a 74-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jul 14, 2008
- Review
- 74 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930003 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK930003 Tubephone Models ER-3A & ER-3 Insert EarphonesEtymotic Research · 1993
- This deviceK081234 GN Otometrics Insert EarphonesGn Otometrics · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930003 | Tubephone Models ER-3A & ER-3 Insert Earphones | Etymotic Research | 1993 | — |
| 0 (this device) | K081234 | GN Otometrics Insert Earphones | Gn Otometrics | 2008 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EWO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EWO device
- #1 K234095 OtoNova/OtoNova Proscore 9.3 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K930003 | Tubephone Models ER-3A & ER-3 Insert EarphonesSummary page 1…Response, (per 21 CFR section 882.1900) Predicate Device: Etyrmotic Research ER-3 Insert Earphones, 5 10(k) #K93 0003 Page 12 510(k) Submission (21 CFR 807.90(e)) for GN Otometrics Ins… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K930003.
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · EWO
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · EWO
173in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EWO
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EWO
13in 2025
MAUDE reports naming product code EWO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 69 | 0 | 1 |
| 2008 | 1 | — | 1 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 3 | 151 | 0 | 2 |
| 2012 | 4 | 137 | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 173 | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 1 | — | 4 | 3 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GN Otometrics Insert Earphones are accessories to the GN Otometrics Audiometers and Chartr EP Auditory Evoked Response systems. The GN Otometrics Insert Earphones devices perform as the means for delivering auditory stimulus to the ears of the patient under test. The interface to the ears of the patient is provided by means of disposable foam eartips, designed to fit infants, children, and adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081234 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081234: GN Otometrics Insert Earphones.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081234
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026