510(k) · Cleared
ClearedEasyscreen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maico Diagnostics GmbH · EWO Audiometer
Cleared on Aug 29, 2017 as substantially equivalent to K103760 (Interacoustics A/S, 2011) and 1 other predicate after a 98-day review. Its family tree reaches back 3 generations to 2006. 1 later device descends from it.
- Decided
- Aug 29, 2017
- Review
- 98 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K060539 (2006). 5 ancestors in all, the oldest K052562 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK060539 DPOAE20 , EclipseInteracoustics A/S, Assens · 2006
- 2 generations backK103760 TITANInteracoustics A/S · 2011
- 1 generation backK130795 TITANInteracoustics A/S · 2013
- This deviceK171506 EasyscreenMaico Diagnostics GmbH · 2017
- Descendant · cites it directly · 0 of its ownK173567 SeraInteracoustics A/S · 2018
Most influential descendants
Showing 1 of 1 · See all- K173567SeraInteracoustics A/S · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K060539 | DPOAE20 , Eclipse | Interacoustics A/S, Assens | 2006 | — |
| −2 | K103760 | TITAN | Interacoustics A/S | 2011 | — |
| −1 | K130795 | TITAN | Interacoustics A/S | 2013 | — |
| 0 (this device) | K171506 | Easyscreen | Maico Diagnostics GmbH | 2017 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 9.3 · 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? (2)
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 |
|---|---|---|---|
| * | K103760 | TITANSummary page 4…4.1050/882.1900) Device regulatory classification: Class II Product Code: EWO/GWJ Predicate Device 1: Titan (with DPOAE440 and ABRIS440), cleared on 05/05/2011 via K103760 Predicate Device 2: Titan (with TEOAE440), cleared on 06/20/2013 via K130795 III. Device Description The device is audiome… | 2011 |
| * | K130795 | TITANSummary page 4…WO/GWJ Predicate Device 1: Titan (with DPOAE440 and ABRIS440), cleared on 05/05/2011 via K103760 Predicate Device 2: Titan (with TEOAE440), cleared on 06/20/2013 via K130795 III. Device Description The device is audiometric equipment used for testing of inner ear and auditory brainstem abnormaliti… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173567 | Sera | 2018 | 0 |
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 11 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K173567 (Interacoustics A/S, 2018) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K103760.
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 device DPOAE and TEOAE modules are intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions or Transient Otoacoustic Emissions technology. The target population for the modules includes all ages. The device ABR module 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…
Read the full statement (122 words)
The device DPOAE and TEOAE modules are intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions or Transient Otoacoustic Emissions technology. The target population for the modules includes all ages.
The device ABR module 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 the ABR module is newborns and infants up to 6 months of age.
The easyScreen is intended to be used by audiologists, ENTs, hearing healthcare professionals, or other trained technicians in a hospital, clinic, healthcare facility or other suitable quiet environment as defined in standard ISO 8253-1.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171506: Easyscreen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171506
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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