510(k) · Cleared
ClearedSera
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interacoustics A/S · EWO Audiometer
Cleared on Feb 14, 2018 as substantially equivalent to K171506 (Maico Diagnostics GmbH, 2017) after an 86-day review. Its family tree reaches back 4 generations to 2006.
- Decided
- Feb 14, 2018
- Review
- 86 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K060539 (2006). 6 ancestors in all, the oldest K052562 (2005). No later device cites it as a predicate yet.
- Root · 4 generations backK060539 DPOAE20 , EclipseInteracoustics A/S, Assens · 2006
- 3 generations backK103760 TITANInteracoustics A/S · 2011
- 2 generations backK130795 TITANInteracoustics A/S · 2013
- 1 generation backK171506 EasyscreenMaico Diagnostics GmbH · 2017
- This deviceK173567 SeraInteracoustics A/S · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K060539 | DPOAE20 , Eclipse | Interacoustics A/S, Assens | 2006 | — |
| −3 | K103760 | TITAN | Interacoustics A/S | 2011 | — |
| −2 | K130795 | TITAN | Interacoustics A/S | 2013 | — |
| −1 | K171506 | Easyscreen | Maico Diagnostics GmbH | 2017 | — |
| 0 (this device) | K173567 | Sera | Interacoustics A/S | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K171506 | EasyscreenSummary page 4…Class II Panel: Ear Nose & Throat / Neurology Classification Regulation: 874.1050/882.1900 Product Code: EWO/GWJ Predicate Device: easyScreen, cleared on 08/29/2017 via K171506 Device Description The device is audiometric equipment used for assisting in detecting of inner ear and auditory brainstem abno… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Sera™ with DPOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. The target population for Sera with DPOAE includes all ages. The Sera™ with TEOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Transient Evoked Otoacoustic Emissions. The target population for Sera with TEOAE includes all ages. The Sera™ with ABRIS is intended…
Read the full statement (156 words)
The Sera™ with DPOAE is intended for use in the audiologic evaluation and documentation of ear disorders using
Distortion Product Otoacoustic Emissions. The target population for Sera with DPOAE includes all ages.
The Sera™ with TEOAE is intended for use in the audiologic evaluation and documentation of ear disorders using
Transient Evoked Otoacoustic Emissions. The target population for Sera with TEOAE includes all ages.
The Sera™ with ABRIS is intended for use in the audiologic evaluation and documentation of ear and nerve disorders
using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The target population for Sera
with ABRIS is newborns.
The Sera™ System is to be used by trained personnel only, such as audiologists, ENT surgeons, doctors, hearing
healthcare professionals or personnel with a similar level of education. The device should not be used without the
necessary knowledge and training to understand its use and how results should be interpreted.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173567 · printed Nov 5, 2026
Cite this page
510(k) Report. “K173567: Sera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K173567
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