# K162037: Eclipse with VEMP

- Pathway: 510(k) (Traditional)
- Applicant: Interacoustics A/S
- Decided: Mar 23, 2017 after 244 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: 5 generations back to K002985 (2000). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143670: Ics Chartr EP 200 with Vemp, Gn Otometrics A/S (2015) Summary page 4.
- K090406: EP15 Software Module, EP25 Software Module, Interacoustics AS (2009) Summary page 4.

## Most influential descendants
- K242954: Integrity V500 (Integrity, Integrity with VEMP) (2024), 0 descendants of its own

## Indications for use
The Eclipse with VEMP (Vestibular Evoked Myogenic Potential) is intended for vestibular evoked myogenic potential testing to assist in the assessment of vestibular function. The target population for Eclipse with VEMP includes patients aged from 8 years and up. The device is to be used only by qualified medical personnel with prior knowledge of the medical and scientific facts underlying the procedure.

Source page: https://510kreport.com/device/K162037
Methodology: https://510kreport.com/methodology