# K081234: GN Otometrics Insert Earphones

- Pathway: 510(k) (Traditional)
- Applicant: Gn Otometrics
- Decided: Jul 14, 2008 after 74 days
- Product code: EWO (Audiometer)
- Device class: 2
- Regulation: 21 CFR 874.1050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930003 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930003: Tubephone Models ER-3A & ER-3 Insert Earphones, Etymotic Research (1993) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K081234
Methodology: https://510kreport.com/methodology