510(k) · Cleared
ClearedAudiometer, Otoacoustic Emission, Auditory Branstem Response Access
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viasys Healthcare, Inc. · EWO Audiometer
Cleared on Aug 12, 2003 as substantially equivalent to K024205 (Everest Biomedical Instruments Co., 2003) and 4 other predicates after a 71-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- Aug 12, 2003
- Review
- 71 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K902540 (1990). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK902540 Gsi 17 Screening AudiometerGrason-Stadler, Inc. · 1990
- 1 generation backK974237 Gsi 70 Audiopath ScreenerGrason-Stadler, Inc. · 1998
- This deviceK031713 Audiometer, Otoacoustic Emission, Auditory Branstem Response AccessViasys Healthcare, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK073384 Smart Coupler, Model M015401Intelligent Hearing Systems · 2008
Most influential descendants
Showing 1 of 1 · See all- K073384Smart Coupler, Model M015401Intelligent Hearing Systems · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902540 | Gsi 17 Screening Audiometer | Grason-Stadler, Inc. | 1990 | — |
| −1 | K974237 | Gsi 70 Audiopath Screener | Grason-Stadler, Inc. | 1998 | — |
| 0 (this device) | K031713 | Audiometer, Otoacoustic Emission, Auditory Branstem Response Access | Viasys Healthcare, Inc. | 2003 | — |
| +1 | K073384 | Smart Coupler, Model M015401 | Intelligent Hearing Systems | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (5)
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 |
|---|---|---|---|
| * | K024205 | Audioscreener Oae+Abr | 2003 |
| * | K974237 | Gsi 70 Audiopath ScreenerSummary page 1…roduct Code Class Trade Name KO24205 Everest Biomedical EWO I1 Audioscreener OAE + ABR I K974237 I Instruments Company Chesterfield, MO… | 1998 |
| * | K934658 | Gsi 60 Dpoae SystemSummary page 1…Chesterfield, MO Grason-Stadler Inc. EWO I1 GSI 70 AudioPath Screener K934658 Grason-Stadler Inc. ETW I1 GSI 60 DPOAE System K911095 Grason-Stadler In… | 1994 |
| * | K911095 | Gsi 37 Auto TympSummary page 1…I1 GSI 70 AudioPath Screener K934658 Grason-Stadler Inc. ETW I1 GSI 60 DPOAE System K911095 Grason-Stadler Inc. ETY I1 GSI 37 Auto Tymp… | 1991 |
| * | K902540 | Gsi 17 Screening AudiometerSummary page 1…ETY I1 GSI 37 Auto Tymp I1 L K902540 Grason-Stadler Inc. EWO I1 GSI 17 Screening… | 1990 |
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 |
|---|---|---|---|
| K073384 | Smart Coupler, Model M015401 | 2008 | 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 13 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K073384 (Intelligent Hearing Systems, 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K024205.
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 Comfort Cup and Ear Tip accessories are for use with non-Grason Stadler (GSI) Audiometer, Otoacoustic Emission and Auditory Brainstem Response devices and are patient applied parts to support auditory evaluation studies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031713 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031713: Audiometer, Otoacoustic Emission, Auditory Branstem Response Access.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031713
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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