# K100661: Earprobe

- Pathway: 510(k) (Traditional)
- Applicant: Path Medical GmbH
- Decided: Jul 1, 2010 after 115 days
- Product code: GWJ (Stimulator, Auditory, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1900
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K902540 (1990). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013977: Echo-Screen T, TA, TD, Tda, TC, Fischer-Zoth Audiologic Systems, Inc. (2002) Summary page 1.

## Recalls of this device
- Nov 6, 2025 · Class II · Z-0940-2026: Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These di

## Indications for use
The Ear Probe is intended to be an accessory to auditory testing equipment that use evoked responses (e.g. DPOAE, ABR) to assess hearing function. * The Ear Probe is capable of both generating and recording sounds in the ear canal. * The Ear Probe is intended for use in infants from 34th week (gestational age) up to 6 months of age. The interface to the patient's ear is provided by means of disposable standard eartips, which are available as separate consumnables.

Source page: https://510kreport.com/device/K100661
Methodology: https://510kreport.com/methodology