510(k) · Cleared
ClearedEP15 Software Module, EP25 Software Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interacoustics AS · EWO Audiometer
Cleared on Jul 22, 2009 as substantially equivalent to K052562 (Interacoustics AS, 2005) after a 155-day review. Its family tree reaches back 1 generation to 2005. 2 later devices descend from it.
- Decided
- Jul 22, 2009
- Review
- 155 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052562 (2005). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK052562 Eclipse (Cabinet Name), TEOAE25, EP15, or the Combination of Systems.Interacoustics AS · 2005
- This deviceK090406 EP15 Software Module, EP25 Software ModuleInteracoustics AS · 2009
- Descendant · cites it directly · 1 of its ownK162037 Eclipse with VEMPInteracoustics A/S · 2017
- Descendant · 2 generations on · 0 of its ownK242954 Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052562 | Eclipse (Cabinet Name), TEOAE25, EP15, or the Combination of Systems. | Interacoustics AS | 2005 | — |
| 0 (this device) | K090406 | EP15 Software Module, EP25 Software Module | Interacoustics AS | 2009 | — |
| +1 | K162037 | Eclipse with VEMP | Interacoustics A/S | 2017 | — |
| +2 | K242954 | Integrity V500 (Integrity, Integrity with VEMP) | Vivosonic, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EWO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EWO device
- #1 K234095 OtoNova/OtoNova Proscore 9.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052562 | Eclipse (Cabinet Name), TEOAE25, EP15, or the Combination of Systems.Summary page 1…5 software module. Common name: Audiometer Classification name: EWO, GWJ Predicate device Eclipse (Cabinet name), TEOAE25, EP15, EP25 or the combination of the systems. K052562 Device description The EP15 and EP25 systems measure auditory brainstem responses picked up by skin electrodes and amplified by… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162037 | Eclipse with VEMP | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · EWO
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · EWO
173in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EWO
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EWO
13in 2025
MAUDE reports naming product code EWO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 69 | 0 | 1 |
| 2008 | 1 | — | 1 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 3 | 151 | 0 | 2 |
| 2012 | 4 | 137 | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 173 | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 1 | — | 4 | 3 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (139 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090406 · printed Nov 5, 2026
Cite this page
510(k) Report. “K090406: EP15 Software Module, EP25 Software Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K090406
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026