510(k) · Cleared
ClearedOtostat Dpoae + Mepa Measurement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mimosa Acoustics, Inc. · EWO Audiometer
Cleared on Mar 28, 2013 as substantially equivalent to K981460 (Mimosa Acoustics, Inc., 1998) and 1 other predicate after a 125-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Mar 28, 2013
- Review
- 125 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K981460 (1998). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK981460 Cub Dis II Dpoae Measurement SystemMimosa Acoustics, Inc. · 1998
- This deviceK123624 Otostat Dpoae + Mepa Measurement SystemMimosa Acoustics, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981460 | Cub Dis II Dpoae Measurement System | Mimosa Acoustics, Inc. | 1998 | — |
| 0 (this device) | K123624 | Otostat Dpoae + Mepa Measurement System | Mimosa Acoustics, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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? (2)
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 |
|---|---|---|---|
| * | K981460 | Cub Dis II Dpoae Measurement SystemSummary page 1…d immittance Classification: OAE and Auditory Impedance Tester Predicate Devices: CUBcDIS-DPOAE Measurement System (1K981460) HearID Wideband Middle Ear Power Analyzer (MEPA) (K053216) Device Des… | 1998 |
| * | K053216 | Hearid Wideband Middle Ear Power AnalyzerSummary page 1…Devices: CUBcDIS-DPOAE Measurement System (1K981460) HearID Wideband Middle Ear Power Analyzer (MEPA) (K053216) Device Description: The OtoStat is a small portable handheld audiometric measurement device for measuring either DPOAE (distort… | 2006 |
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.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 intended use of the OtoStat DPOAE Measurement is to determine the presence of cochlear function. The intended use of the OtoStat MEPA Middle Ear Power Analyzer is to characterize the middle ear status and to assist in diagnosing middle ear pathologies. The intended use of the OtoStat DPOAE+MEPA is to determine the presence of cochlear and middle ear functions and to assist in differential diagnosis between cochlear and middle ear dysfunctions. The…
Read the full statement (131 words)
The intended use of the OtoStat DPOAE Measurement is to determine the presence of cochlear function.
The intended use of the OtoStat MEPA Middle Ear Power Analyzer is to characterize the middle ear status and to assist in diagnosing middle ear pathologies.
The intended use of the OtoStat DPOAE+MEPA is to determine the presence of cochlear and middle ear functions and to assist in differential diagnosis between cochlear and middle ear dysfunctions.
The OtoStat MEPA system measures various acoustic properties of the ear, namely power reflectance, power absorbance, transmittance, wideband inimittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear.
The device is suitable for all populations including new-born infants.
The device is to be used by trained personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123624: Otostat Dpoae + Mepa Measurement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123624
Report an extraction error
Are you the manufacturer?
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