# K131141: Earprobe

- Pathway: 510(k) (Traditional)
- Applicant: Path Medical GmbH
- Decided: Jun 27, 2013 after 65 days
- Product code: GWJ (Stimulator, Auditory, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1900
- Recalls of this device: none
- 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.

## 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 all ages. The interface to the patient's ear is provided by means of disposable standard eartips which are available as separate consumables.

Source page: https://510kreport.com/device/K131141
Methodology: https://510kreport.com/methodology