510(k) · Cleared
ClearedAudioscreener Oae+Abr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Everest Biomedical Instruments Co. · EWO Audiometer
Cleared on Mar 7, 2003 as substantially equivalent to K001058 (Kedly, Inc., 2000) after a 77-day review. Its family tree reaches back 1 generation to 2000. 5 later devices descend from it.
- Decided
- Mar 7, 2003
- Review
- 77 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001058 (2000). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK001058 Audioscreener Oae + AbrKedly, Inc. · 2000
- This deviceK024205 Audioscreener Oae+AbrEverest Biomedical Instruments Co. · 2003
- Descendant · cites it directly · 2 of its ownK143395 Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR…Otodynamics, Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK031713 Audiometer, Otoacoustic Emission, Auditory Branstem Response AccessViasys Healthcare, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK234095 OtoNova/OtoNova ProOtodynamics · 2024
- Descendant · 2 generations on · 0 of its ownK240430 Otoport ProOtodynamics, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK073384 Smart Coupler, Model M015401Intelligent Hearing Systems · 2008
Most influential descendants
Showing 5 of 5 · See all- K143395Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck…Otodynamics, Ltd. · 2015 · cites it directly2descendants
- K031713Audiometer, Otoacoustic Emission, Auditory Branstem Response AccessViasys Healthcare, Inc. · 2003 · cites it directly1descendant
- K234095OtoNova/OtoNova ProOtodynamics · 2024 · 2 generations on0descendants
- K240430Otoport ProOtodynamics, Ltd. · 2024 · 2 generations on0descendants
- K073384Smart Coupler, Model M015401Intelligent Hearing Systems · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001058 | Audioscreener Oae + Abr | Kedly, Inc. | 2000 | — |
| 0 (this device) | K024205 | Audioscreener Oae+Abr | Everest Biomedical Instruments Co. | 2003 | — |
| +1 | K143395 | Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR… | Otodynamics, Ltd. | 2015 | — |
| +1 | K031713 | Audiometer, Otoacoustic Emission, Auditory Branstem Response Access | Viasys Healthcare, Inc. | 2003 | — |
| +2 | K234095 | OtoNova/OtoNova Pro | Otodynamics | 2024 | — |
| +2 | K240430 | Otoport Pro | Otodynamics, Ltd. | 2024 | — |
| +2 | K073384 | Smart Coupler, Model M015401 | Intelligent Hearing Systems | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K001058 | Audioscreener Oae + Abr | 2000 |
What descends from it? (5)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K143395 (Otodynamics, Ltd., 2015) has gone furthest, with 2 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 Audioscreener OAE+ABR may be used for patients of all ages, from newborn infants through adults. The Distortion Product Otoacoustic Emissions, Transient Evoked Otoacoustic Emissions, and Auditory Brainstem Response tests are indicated for use in screening individuals for hearing loss for whom behavioral audiometric responses are deemed to be unreliable, such as in infants, young children, and uncooperative or cognitively impaired adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024205 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024205: Audioscreener Oae+Abr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024205
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