510(k) · Cleared
ClearedAudx Otoacoustic Emissions Measurement System with Audx I/O Function
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Medical Incorporated · EWO Audiometer
Cleared on Dec 28, 2011 as substantially equivalent to K021801 (Bio-Logic Systems Corp., 2002) and 3 other predicates after a 201-day review. Its family tree reaches back 5 generations to 1993. 1 later device descends from it.
- Decided
- Dec 28, 2011
- Review
- 201 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K930328 (1993). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK930328 Navigator & Traveler Evoked Postential ProductBio-Logic Systems Corp. · 1993
- 4 generations backK992807 Bio-Logic Evoked Potential for Abaer IBio-Logic Systems Corp. · 1999
- 3 generations backK994149 Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.Bio-Logic Systems Corp. · 1999
- 2 generations backK021215 Bio-Logic Abaer CubBio-Logic Systems Corp. · 2002
- 1 generation backK021801 Bio-Logic Abaer Cub with Integrated Oae & Abr FunctionsBio-Logic Systems Corp. · 2002
- This deviceK111618 Audx Otoacoustic Emissions Measurement System with Audx I/O FunctionNatus Medical Incorporated · 2011
- Descendant · cites it directly · 0 of its ownK122496 Audx Pro Otoacoustic Emissions Measurement SystemBio-Logic Systems Corp. · 2012
Most influential descendants
Showing 1 of 1 · See all- K122496Audx Pro Otoacoustic Emissions Measurement SystemBio-Logic Systems Corp. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930328 | Navigator & Traveler Evoked Postential Product | Bio-Logic Systems Corp. | 1993 | — |
| −4 | K992807 | Bio-Logic Evoked Potential for Abaer I | Bio-Logic Systems Corp. | 1999 | — |
| −3 | K994149 | Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro. | Bio-Logic Systems Corp. | 1999 | — |
| −2 | K021215 | Bio-Logic Abaer Cub | Bio-Logic Systems Corp. | 2002 | — |
| −1 | K021801 | Bio-Logic Abaer Cub with Integrated Oae & Abr Functions | Bio-Logic Systems Corp. | 2002 | — |
| 0 (this device) | K111618 | Audx Otoacoustic Emissions Measurement System with Audx I/O Function | Natus Medical Incorporated | 2011 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K021801 | Bio-Logic Abaer Cub with Integrated Oae & Abr FunctionsSummary page 1…X I/O Function Common or Usual Name: Audiometer Classification Name and Number: Audiometer 21 CFR 874.1 050, Product Code: EWO Predicate Devices: K021801 ABaer Cub with Automated OAE and ABR K9641 32 Bio-logic Scout and Scout Sport Otoacoustic… | 2002 |
| * | K964132 | Modification to Otoacoustic Emissions (OAE0 Test InstrumentSummary page 1…d Number: Audiometer 21 CFR 874.1 050, Product Code: EWO Predicate Devices: K021801 ABaer Cub with Automated OAE and ABR K9641 32 Bio-logic Scout and Scout Sport Otoacoustic Emissions (OAE) Test Instruments with TEOAE and DPOAE… | 1997 |
| * | K974076 | Sport/Audx Oae Test Instrument with Bio-Logic Ear ProbeSummary page 1…E Software, incorporating the modifications of Automated Input / Output Software Functions K974076 Sport / AuDX OAE Test Instrument with Bio-logic Ear Probe K072033 Otodynamic… | 1998 |
| * | K072033 | Otodynamics OtoportSummary page 1…tput Software Functions K974076 Sport / AuDX OAE Test Instrument with Bio-logic Ear Probe K072033 Otodynamics Otoport Device Description: The AuDX I/0 Function is a Windows® based software appli… | 2007 |
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 |
|---|---|---|---|
| K122496 | Audx Pro Otoacoustic Emissions Measurement System | 2012 | 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 18 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K122496 (Bio-Logic Systems Corp., 2012) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K021801.
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Otoacoustic Emissions Measurement System produces 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 as a result of normal peripheral hearing processes. The AuDX device performs both transient evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) tests that can be utilized in hearing screening…
Read the full statement (321 words)
The AuDX Otoacoustic Emissions Measurement System produces 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 as a result of normal peripheral hearing processes. The AuDX device performs both transient evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) tests that can be utilized in hearing screening and diagnostic test environments. The AuDX I/O is a software option intended to provide additional diagnostic capability and to be used in conjunction with the AuDX system. The AuDX I/O software option enables the AuDX device user to perform DPOAE testing at different stimulus intensities in order to obtain the 'DPOAE Input / Output (I/O) function' at different test frequencies, frequency ratios and intensity levels. The graphical representation of the test results in the form of stimulus level presented versus measured DPOAE level at each tested frequency provides an effective way for the user to view and evaluate stimulus level-sensitive information about DPOAE responses.
As an OAE based screening tool, AuDX is indicated for use by any personnel (nurses, technicians, volunteers) who are trained to operate the device for the purpose of performing an objective, automated physiologic screening measure with pass/refer result requiring no further clinical interpretation. Additionally, as a tool that can provide diagnostic information, the device is indicated for use by trained health care professionals (audiologists, physicians) for the purpose of further assessing cochlear function in the diagnosis and treatment of hearing disorders, since additional information may be obtained by viewing the details of the performed otoacoustic emissions test and by obtaining the DPOAE I/O functions. 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/K111618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111618: Audx Otoacoustic Emissions Measurement System with Audx I/O Function.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111618
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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