510(k) · Cleared
ClearedOtoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Otodynamics, Ltd. · EWO Audiometer
Cleared on Feb 23, 2015 as substantially equivalent to K072033 (Otodynamics, Ltd., 2007) and 2 other predicates after an 89-day review. Its family tree reaches back 6 generations to 1990. 2 later devices descend from it.
- Decided
- Feb 23, 2015
- Review
- 89 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K902540 (1990). 18 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK902540 Gsi 17 Screening AudiometerGrason-Stadler, Inc. · 1990
- 5 generations backK974237 Gsi 70 Audiopath ScreenerGrason-Stadler, Inc. · 1998
- 4 generations backK982642 Echo-ScreenFischer-Zoth Audiologic Systems, Inc. · 1998
- 3 generations backK013977 Echo-Screen T, TA, TD, Tda, TCFischer-Zoth Audiologic Systems, Inc. · 2002
- 2 generations backK122067 Type 1077 AccuscreenGn Otometrics · 2012
- 1 generation backK132957 Madsen Accuscreen Type 1077Gn Otometrics · 2014
- This deviceK143395 Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR…Otodynamics, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK234095 OtoNova/OtoNova ProOtodynamics · 2024
- Descendant · cites it directly · 0 of its ownK240430 Otoport ProOtodynamics, Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K902540 | Gsi 17 Screening Audiometer | Grason-Stadler, Inc. | 1990 | — |
| −5 | K974237 | Gsi 70 Audiopath Screener | Grason-Stadler, Inc. | 1998 | — |
| −4 | K982642 | Echo-Screen | Fischer-Zoth Audiologic Systems, Inc. | 1998 | — |
| −3 | K013977 | Echo-Screen T, TA, TD, Tda, TC | Fischer-Zoth Audiologic Systems, Inc. | 2002 | — |
| −2 | K122067 | Type 1077 Accuscreen | Gn Otometrics | 2012 | — |
| −1 | K132957 | Madsen Accuscreen Type 1077 | Gn Otometrics | 2014 | — |
| 0 (this device) | K143395 | Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR… | Otodynamics, Ltd. | 2015 | — |
| +1 | K234095 | OtoNova/OtoNova Pro | Otodynamics | 2024 | — |
| +1 | K240430 | Otoport Pro | Otodynamics, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K072033 | Otodynamics OtoportSummary page 5…Nose & Throat)] Evoked response auditory stimulator [class II, 21 CFR Section 882.1900; product code GWJ; Panel 84 (Neurology)] Predicate Devices: Otodynamics Otoport (K072033) for otoacoustic emission functions GSI Audioscreener (K024205) and GN Otometrics Madsen AccuScreen Type 1077 (K132957) for audi… | 2007 |
| * | K024205 | Audioscreener Oae+AbrSummary page 5…21 CFR Section 882.1900; product code GWJ; Panel 84 (Neurology)] Predicate Devices: Otodynamics Otoport (K072033) for otoacoustic emission functions GSI Audioscreener (K024205) and GN Otometrics Madsen AccuScreen Type 1077 (K132957) for auditory brainstem functions Device Description: The Otodynamics O… | 2003 |
| * | K132957 | Madsen Accuscreen Type 1077Summary page 5…rology)] Predicate Devices: Otodynamics Otoport (K072033) for otoacoustic emission functions GSI Audioscreener (K024205) and GN Otometrics Madsen AccuScreen Type 1077 (K132957) for auditory brainstem functions Device Description: The Otodynamics Otoport/Otocheck OAE+ABR device is a compact, handheld, b… | 2014 |
What descends from it? (2)
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?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K234095 (Otodynamics, 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K072033.
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Otodynamics Otoport/Otocheck OAE+ABR device is indicated for use when there is a requirement to screen for hearing disorders by objective and non-invasive means. ABR, TEOAE and DPOAE screening test results are automatically interpreted and a clear ‘Pass’ or ‘Refer’ result is presented to the user who will be a trained screener, audiologist or medical professional. Use of the device is indicated when the patient is unable to give reliable voluntary…
Read the full statement (158 words)
The Otodynamics Otoport/Otocheck OAE+ABR device is indicated for use when there is a requirement to screen for
hearing disorders by objective and non-invasive means. ABR, TEOAE and DPOAE screening test results are
automatically interpreted and a clear ‘Pass’ or ‘Refer’ result is presented to the user who will be a trained screener,
audiologist or medical professional. Use of the device is indicated when the patient is unable to give reliable voluntary
responses to sound, especially with infants. Use of the device facilitates the early detection of hearing loss and its
characterization.
The TEOAE and DPOAE analytical functions of the device are indicated when objective non-invasive clinical
investigations require the characterization and monitoring of the functional status of the peripheral auditory function. For
this purpose the device is intended to be used by audiologists or other audiologically skilled professionals. These TEOAE
and DPOAE tests are applicable to populations of any age to obtain objective evidence of peripheral auditory function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143395 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143395: Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143395
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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