510(k) · Cleared
ClearedILO292 DP Echoport Plus Oae System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Otodynamics, Ltd. · EWO Audiometer
Cleared on Dec 11, 1998 after a 79-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Dec 11, 1998
- Review
- 79 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK983350 ILO292 DP Echoport Plus Oae SystemOtodynamics, Ltd. · 1998
- Descendant · cites it directly · 6 of its ownK072033 Otodynamics OtoportOtodynamics, Ltd. · 2007
- Descendant · 2 generations on · 2 of its ownK143395 Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR…Otodynamics, Ltd. · 2015
- 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 ownK234095 OtoNova/OtoNova ProOtodynamics · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K072033Otodynamics OtoportOtodynamics, Ltd. · 2007 · cites it directly6descendants
- K143395Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck…Otodynamics, Ltd. · 2015 · 2 generations on2descendants
- 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
- K234095OtoNova/OtoNova ProOtodynamics · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983350 | ILO292 DP Echoport Plus Oae System | Otodynamics, Ltd. | 1998 | — |
| +1 | K072033 | Otodynamics Otoport | Otodynamics, Ltd. | 2007 | — |
| +2 | K143395 | Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR… | Otodynamics, Ltd. | 2015 | — |
| +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 | K234095 | OtoNova/OtoNova Pro | Otodynamics | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
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, K072033 (Otodynamics, Ltd., 2007) has gone furthest, with 6 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 Otodynamics L0288 ECHOPORTplus OAE System is designed to perform an auditory screening function by objectively testing for normal function of the cochlea. The system is designed to operate standalone, or optionally interface to an IBM compatible PC, using the parallel port.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983350 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983350: ILO292 DP Echoport Plus Oae System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983350
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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