510(k) · Cleared
ClearedOtowave 202 Portable Tympanometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amplivox, Ltd. · NAS Tympanometer
Cleared on Apr 23, 2015 as substantially equivalent to K081841 (Amplivox, Ltd., 2008) after an 87-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Apr 23, 2015
- Review
- 87 days
- Class
- Class II
- Product code
- NAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K925585 (1993). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925585 | Gsi 38 Auto Tymp | Lucas Grason-Stadler, Inc. | 1993 | — |
| −1 | K081841 | Amplivox Otowave 102 Hand Held Portable Tympanometer | Amplivox, Ltd. | 2008 | — |
| 0 (this device) | K150163 | Otowave 202 Portable Tympanometer | Amplivox, Ltd. | 2015 | — |
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 NAS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K081841 | Amplivox Otowave 102 Hand Held Portable TympanometerSummary page 4…ster. Code: NAS Regulation: 874.1090 Auditory impedance tester Common/Usual Name: Tympanometer 2. Equivalent legally marketed devices: Amplivox Otowave 102, K081841 3. Description of the Device: The Otowave 202 relies heavily on long-established practice in the clinical area of middle-… | 2008 |
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?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 15.4 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All NAS devicesNAS Tympanometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NAS
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · NAS
Too few NAS 510(k)s in any year since 2007 to give a median.
Recalls per year · NAS
No recall names NAS since 2007.
Adverse event reports per year · NAS
1in 2025
MAUDE reports naming product code NAS, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Amplivox Otowave 202 is designed for use by trained operators (audiologists, general practitioners, hearing aid dispensers, and child health professionals) in hospitals, ENT clinics, and audiologist offices for the detection of possible otologic disorders in the general population associated with the functioning of the middle ear. The instrument performs two types of measurement: Tympanometry is used to measure the compliance of the tympanic membrane…
Read the full statement (104 words)
The Amplivox Otowave 202 is designed for use by trained operators (audiologists, general practitioners, hearing aid dispensers, and child health professionals) in hospitals, ENT clinics, and audiologist offices for the detection of possible otologic disorders in the general population associated with the functioning of the middle ear. The instrument performs two types of measurement: Tympanometry is used to measure the compliance of the tympanic membrane and middle ear at a fixed frequency over a range of pressures. Reflex tests are used to measure stapedial reflexes. The Otowave measures ipsilateral reflexes and, when selected, reflex measurement is automatically carried out after a tympanogram is taken.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150163 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150163: Otowave 202 Portable Tympanometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150163
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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