510(k) · Cleared
ClearedMadsen Zodiac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gn Otometrics · ETY Tester, Auditory Impedance
Cleared on Sep 1, 2016 as substantially equivalent to K033645 (Gn Otometrics A/S, 2004) after a 72-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Sep 1, 2016
- Review
- 72 days
- Class
- Class II
- Product code
- ETY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K910247 (1991). 4 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 | K910247 | Zodiac 901 Middle-Ear Analyzer | Madsen Electronics (Canada), Ltd. | 1991 | — |
| −1 | K033645 | Otoflex 100 Tye 1012 | Gn Otometrics A/S | 2004 | — |
| 0 (this device) | K161707 | Madsen Zodiac | Gn Otometrics | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 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? (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 |
|---|---|---|---|
| * | K033645 | Otoflex 100 Tye 1012Summary page 4…Auditory impedance tester. Product Code: ETY Regulation Number 874.1090 2. Equivalent legally marketed device: 510(K) Number. K033645 Proprietary-Trade Name: OTOflex 100 Type 1012, GN Otometrics A/S. Common Name: Tester, Auditory Impe… | 2004 |
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 25 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K033645.
How does its category compare?
All ETY devicesETY Tester, Auditory Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Madsen Zodiac (Type 1096) is an auditory impedance tester that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. This device is also used to measure the acoustic reflex threshold and decay testing as well as eustachian tube function testing for intact and perforated tympanic membranes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161707 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161707: Madsen Zodiac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161707
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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