510(k) · Cleared
ClearedEro Scan Oae Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Etymotic Research · EWO Audiometer
Cleared on Mar 12, 2001 after a 53-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Mar 12, 2001
- Review
- 53 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK010165 Ero Scan Oae Test SystemEtymotic Research · 2001
- Descendant · cites it directly · 1 of its ownK150491 ER36 Series OAE Test SystemEtymotic Research, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK180287 GSI CortiGrason-Stadler, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK112733 ER35 Ero-Scan Pro Hearing Test SystemEtymotic Research, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK070880 ER35 Ero-Scan Pro Hearing Test SystemEtymotic Research, Inc. · 2007
Most influential descendants
Showing 4 of 4 · See all- K150491ER36 Series OAE Test SystemEtymotic Research, Inc. · 2015 · cites it directly1descendant
- K180287GSI CortiGrason-Stadler, Inc. · 2018 · 2 generations on0descendants
- K112733ER35 Ero-Scan Pro Hearing Test SystemEtymotic Research, Inc. · 2011 · cites it directly0descendants
- K070880ER35 Ero-Scan Pro Hearing Test SystemEtymotic Research, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010165 | Ero Scan Oae Test System | Etymotic Research | 2001 | — |
| +1 | K150491 | ER36 Series OAE Test System | Etymotic Research, Inc. | 2015 | — |
| +2 | K180287 | GSI Corti | Grason-Stadler, Inc. | 2018 | — |
| +1 | K112733 | ER35 Ero-Scan Pro Hearing Test System | Etymotic Research, Inc. | 2011 | — |
| +1 | K070880 | ER35 Ero-Scan Pro Hearing Test System | Etymotic Research, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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, K150491 (Etymotic Research, Inc., 2015) has gone furthest, with 1 descendant 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 | — |
https://510kreport.com/device/K010165 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010165: Ero Scan Oae Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010165
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026