# K090406: EP15 Software Module, EP25 Software Module

- Pathway: 510(k) (Traditional)
- Applicant: Interacoustics AS
- Decided: Jul 22, 2009 after 155 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 K052562 (2005). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052562: Eclipse (Cabinet Name), TEOAE25, EP15, or the Combination of Systems., Interacoustics AS (2005) Summary page 1.

## Most influential descendants
- K162037: Eclipse with VEMP (2017), 1 descendant of its own
- K242954: Integrity V500 (Integrity, Integrity with VEMP) (2024), 0 descendants of its own

## Indications for use
The Interacoustics EP systems, EP15 and EP25, are intended to assist in the evaluation, documentation and diagnosis of ear disorders on human beings. EP15/25 is a 2 channel ABR and the automatic recording of ABR waveforms makes it well suited for waveform based screening and the manual programmability options allow for comprehensive clinical use ranging from frequency specific threshold test to operating room applications and cochlear implant tests. The EP15 is a basic unit allowing only recording of the Auditory Brainstem Response (ABR), while the EP25 allows recording of the ABR and earlier and later potentials. The Interacoustics TEOAE25 system is intended for determining Cochlear function using Transient Evoked Otoaccoustic Emission click stimuli. Both of these systems are of particular interest to Ear, Nose, and Throat doctors, Neurology specialties, Audiologist and other health professionals concerned with measuring auditory functions.

Source page: https://510kreport.com/device/K090406
Methodology: https://510kreport.com/methodology