510(k) · Cleared
ClearedAmplivox Otowave 102 Hand Held Portable Tympanometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amplivox, Ltd. · ETY Tester, Auditory Impedance
Cleared on Jul 16, 2008 as substantially equivalent to K925585 (Lucas Grason-Stadler, Inc., 1993) and 1 other predicate after a 16-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Jul 16, 2008
- Review
- 16 days
- Class
- Class II
- Product code
- ETY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K925585 (1993). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K150163Otowave 202 Portable TympanometerAmplivox, Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925585 | Gsi 38 Auto Tymp | Lucas Grason-Stadler, Inc. | 1993 | — |
| 0 (this device) | K081841 | Amplivox Otowave 102 Hand Held Portable Tympanometer | Amplivox, Ltd. | 2008 | — |
| +1 | K150163 | Otowave 202 Portable Tympanometer | Amplivox, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 ETY? 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? (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 |
|---|---|---|---|
| * | K925585 | Gsi 38 Auto TympSummary page 1…oduct code, no 51 0(k)s under this code) Audiometer: EWO or Tester, auditory impedance ETY Common/Usual Name: Tympanometer. 2. Equivalent legally marketed devices: K925585, GSI 38 AUTO TYMP LUCAS GRASON- STADLER, INC. and K060885 the Maico Ml 44 Tympanometer. (Plus numerous others).. 3. Indicatio… | 1993 |
| * | K060885 | Model MI 44 TympanometerSummary page 1…r Tester, auditory impedance ETY Common/Usual Name: Tympanometer. 2. Equivalent legally marketed devices: K925585, GSI 38 AUTO TYMP LUCAS GRASON- STADLER, INC. and K060885 the Maico Ml 44 Tympanometer. (Plus numerous others).. 3. Indications for Use (intended use) The Amplivox Otowave is designed fo… | 2006 |
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 |
|---|---|---|---|
| K150163 | Otowave 202 Portable Tympanometer | 2015 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K150163 (Amplivox, Ltd., 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ETY devicesETY Tester, Auditory Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · ETY
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · ETY
Too few ETY 510(k)s in any year since 2007 to give a median.
Recalls per year · ETY
No recall names ETY since 2007.
Adverse event reports per year · ETY
1in 2025
MAUDE reports naming product code ETY, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Amplivox Otowave is designed for use by trained operators in hospitals. ENT clinics, and audiologist offices for the detection of possible otologic disorders 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/K081841 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081841: Amplivox Otowave 102 Hand Held Portable Tympanometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081841
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