510(k) · Cleared
ClearedEclipse (Cabinet Name), TEOAE25, EP15, or the Combination of Systems.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interacoustics AS · EWO Audiometer
Cleared on Dec 23, 2005 after a 95-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.
- Decided
- Dec 23, 2005
- Review
- 95 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK052562 Eclipse (Cabinet Name), TEOAE25, EP15, or the Combination of Systems.Interacoustics AS · 2005
- Descendant · cites it directly · 4 of its ownK130795 TITANInteracoustics A/S · 2013
- Descendant · cites it directly · 2 of its ownK090406 EP15 Software Module, EP25 Software ModuleInteracoustics AS · 2009
- Descendant · 2 generations on · 1 of its ownK171506 EasyscreenMaico Diagnostics GmbH · 2017
- Descendant · 2 generations on · 1 of its ownK162037 Eclipse with VEMPInteracoustics A/S · 2017
- Descendant · 3 generations on · 0 of its ownK242954 Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K130795TITANInteracoustics A/S · 2013 · cites it directly4descendants
- K090406EP15 Software Module, EP25 Software ModuleInteracoustics AS · 2009 · cites it directly2descendants
- K171506EasyscreenMaico Diagnostics GmbH · 2017 · 2 generations on1descendant
- K162037Eclipse with VEMPInteracoustics A/S · 2017 · 2 generations on1descendant
- K242954Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052562 | Eclipse (Cabinet Name), TEOAE25, EP15, or the Combination of Systems. | Interacoustics AS | 2005 | — |
| +1 | K130795 | TITAN | Interacoustics A/S | 2013 | — |
| +1 | K090406 | EP15 Software Module, EP25 Software Module | Interacoustics AS | 2009 | — |
| +2 | K171506 | Easyscreen | Maico Diagnostics GmbH | 2017 | — |
| +2 | K162037 | Eclipse with VEMP | Interacoustics A/S | 2017 | — |
| +3 | K242954 | Integrity V500 (Integrity, Integrity with VEMP) | Vivosonic, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 9.3 · 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K130795 (Interacoustics A/S, 2013) has gone furthest, with 4 descendants of its own.
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 510(k) statement.
https://510kreport.com/device/K052562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052562: Eclipse (Cabinet Name), TEOAE25, EP15, or the Combination of Systems..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052562
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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