510(k) · Cleared
ClearedBio-Logic Emav Emission Averaging Otoacoustic Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Logic Systems Corp. · EWO Audiometer
Cleared on Dec 21, 1994 after an 86-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Dec 21, 1994
- Review
- 86 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK944735 Bio-Logic Emav Emission Averaging Otoacoustic TestBio-Logic Systems Corp. · 1994
- Descendant · cites it directly · 4 of its ownK964132 Modification to Otoacoustic Emissions (OAE0 Test InstrumentBio-Logic Systems Corp. · 1997
- Descendant · 2 generations on · 1 of its ownK112247 A Baer with Abaer I/O FunctionNatus Medical Incorporated · 2012
- Descendant · 2 generations on · 1 of its ownK111618 Audx Otoacoustic Emissions Measurement System with Audx I/O FunctionNatus Medical Incorporated · 2011
- Descendant · 3 generations on · 0 of its ownK122496 Audx Pro Otoacoustic Emissions Measurement SystemBio-Logic Systems Corp. · 2012
- Descendant · 2 generations on · 0 of its ownK121512 Scout Sport Otoacoustic Emissions Measurement SystemBio-Logic Systems Corp. · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K964132Modification to Otoacoustic Emissions (OAE0 Test InstrumentBio-Logic Systems Corp. · 1997 · cites it directly4descendants
- K112247A Baer with Abaer I/O FunctionNatus Medical Incorporated · 2012 · 2 generations on1descendant
- K111618Audx Otoacoustic Emissions Measurement System with Audx I/O FunctionNatus Medical Incorporated · 2011 · 2 generations on1descendant
- K122496Audx Pro Otoacoustic Emissions Measurement SystemBio-Logic Systems Corp. · 2012 · 3 generations on0descendants
- K121512Scout Sport Otoacoustic Emissions Measurement SystemBio-Logic Systems Corp. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944735 | Bio-Logic Emav Emission Averaging Otoacoustic Test | Bio-Logic Systems Corp. | 1994 | — |
| +1 | K964132 | Modification to Otoacoustic Emissions (OAE0 Test Instrument | Bio-Logic Systems Corp. | 1997 | — |
| +2 | K112247 | A Baer with Abaer I/O Function | Natus Medical Incorporated | 2012 | — |
| +2 | K111618 | Audx Otoacoustic Emissions Measurement System with Audx I/O Function | Natus Medical Incorporated | 2011 | — |
| +3 | K122496 | Audx Pro Otoacoustic Emissions Measurement System | Bio-Logic Systems Corp. | 2012 | — |
| +2 | K121512 | Scout Sport Otoacoustic Emissions Measurement System | Bio-Logic Systems Corp. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 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 9.4 · 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
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?
- Of its descendants, K964132 (Bio-Logic Systems Corp., 1997) 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 | — |
https://510kreport.com/device/K944735 · printed Nov 4, 2026
Cite this page
510(k) Report. “K944735: Bio-Logic Emav Emission Averaging Otoacoustic Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944735
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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