510(k) · Cleared
ClearedVivo 200 DPS Vivoscan Version 2.0 Oae Audiometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vivosonic, Inc. · EWO Audiometer
Cleared on Oct 27, 2003 after a 27-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 27, 2003
- Review
- 27 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (1)
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 |
|---|---|---|---|
| * | — | Vivo 200 DPS OAE Audiometer Named without a submission number |
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.
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 Vivo 200 DPS VivoScan Version 2.0 is indicated for use when it is necessary for a trained health care professional (for example an Audiologist) to measure or determine cochlear function by measuring, recording and displaying otoacoustic emissions. This device does not measure hearing, but helps to determine whether or not a hearing loss may be present, requiring further evaluation. The Vivo 200 DPS VivoScan Version 2.0 does not measure hearing per…
Read the full statement (178 words)
The Vivo 200 DPS VivoScan Version 2.0 is indicated for use when it is necessary for a trained health care professional (for example an Audiologist) to measure or determine cochlear function by measuring, recording and displaying otoacoustic emissions. This device does not measure hearing, but helps to determine whether or not a hearing loss may be present, requiring further evaluation.
The Vivo 200 DPS VivoScan Version 2.0 does not measure hearing per se, but measures whether or not the cochlear hair cells are functioning. This device does not determine hearing levels, but allows the operator to establish specific pass or refer criteria.
The Vivo 200 DPS VivoScan Version 2.0 is indicated for patients of all ages from newborn through adults, to and including geriatric patients. The otoacoustic emissions test is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults.
The Vivo 200 DPS VivoScan Version 2.0 is a prescription device. The labeling instructions and user operations are designed for trained professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033108 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033108: Vivo 200 DPS Vivoscan Version 2.0 Oae Audiometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033108
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026