510(k) · Cleared
ClearedAudx Pro Otoacoustic Emissions Measurement System
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 Nov 1, 2012 as substantially equivalent to K111618 (Natus Medical Incorporated, 2011) and 2 other predicates after a 77-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Nov 1, 2012
- Review
- 77 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K930328 (1993). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK930328 Navigator & Traveler Evoked Postential ProductBio-Logic Systems Corp. · 1993
- 5 generations backK992807 Bio-Logic Evoked Potential for Abaer IBio-Logic Systems Corp. · 1999
- 4 generations backK994149 Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.Bio-Logic Systems Corp. · 1999
- 3 generations backK021215 Bio-Logic Abaer CubBio-Logic Systems Corp. · 2002
- 2 generations backK021801 Bio-Logic Abaer Cub with Integrated Oae & Abr FunctionsBio-Logic Systems Corp. · 2002
- 1 generation backK111618 Audx Otoacoustic Emissions Measurement System with Audx I/O FunctionNatus Medical Incorporated · 2011
- This deviceK122496 Audx Pro Otoacoustic Emissions Measurement SystemBio-Logic Systems Corp. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930328 | Navigator & Traveler Evoked Postential Product | Bio-Logic Systems Corp. | 1993 | — |
| −5 | K992807 | Bio-Logic Evoked Potential for Abaer I | Bio-Logic Systems Corp. | 1999 | — |
| −4 | K994149 | Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro. | Bio-Logic Systems Corp. | 1999 | — |
| −3 | K021215 | Bio-Logic Abaer Cub | Bio-Logic Systems Corp. | 2002 | — |
| −2 | K021801 | Bio-Logic Abaer Cub with Integrated Oae & Abr Functions | Bio-Logic Systems Corp. | 2002 | — |
| −1 | K111618 | Audx Otoacoustic Emissions Measurement System with Audx I/O Function | Natus Medical Incorporated | 2011 | — |
| 0 (this device) | K122496 | Audx Pro Otoacoustic Emissions Measurement System | Bio-Logic Systems Corp. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2007 | 1 | 0 |
| 2012 | 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? (3)
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 |
|---|---|---|---|
| * | K111618 | Audx Otoacoustic Emissions Measurement System with Audx I/O FunctionSummary page 3…measured OAE test parameters, The AuDX Pro Otoacoustic Emissions Measurement System is equivalent to the devices cleared under K1 11618, K1 12247, and K072033. Nonclinical Tests: Design verification and validation were performed to assure… | 2011 |
| * | K112247 | A Baer with Abaer I/O FunctionSummary page 3…The AuDX Pro Otoacoustic Emissions Measurement System is equivalent to the devices cleared under K1 11618, K1 12247, and K072033. Nonclinical Tests: Design verification and validation were performed to assure that the Au… | 2012 |
| * | K072033 | Otodynamics OtoportSummary page 1…acoustic Emissions Measurement System with AuDX 1/0 Function Ki 12247 ABaer with ABaer 1/O K072033 Otoport Device Description: The AuDX Pro Qtoacoustic Emissions Measurement System is a handheld… | 2007 |
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 19 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 13 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. 2012, 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 AuDX Pro Otoacoustic Emissions Measurement System delivers controlled acoustic signals in the ear canal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear. The AuDX Pro device performs transient evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) tests. AuDX Pro is indicated for use by trained health care professionals (audiologists…
Read the full statement (135 words)
The AuDX Pro Otoacoustic Emissions Measurement System delivers controlled acoustic signals in the ear canal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear. The AuDX Pro device performs transient evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) tests.
AuDX Pro is indicated for use by trained health care professionals (audiologists, physicians) and personnel (nurses, technicians) who are trained to operate the device under their supervision to perform otoacoustic emissions testing to assess cochlear function.
The device can be used for patients of all ages, from newborn infants through adults, to include geriatric patients. The otoacoustic emissions test is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable, such as infants, young children, and cognitively impaired adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122496: Audx Pro Otoacoustic Emissions Measurement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122496
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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