510(k) · Cleared
ClearedOtoflex 100 Tye 1012
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gn Otometrics A/S · ETY Tester, Auditory Impedance
Cleared on Mar 31, 2004 as substantially equivalent to K910247 (Madsen Electronics (Canada), Ltd., 1991) and 2 other predicates after a 132-day review. Its family tree reaches back 1 generation to 1991. 3 later devices descend from it.
- Decided
- Mar 31, 2004
- Review
- 132 days
- Class
- Class II
- Product code
- ETY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K910247 (1991). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK910247 Zodiac 901 Middle-Ear AnalyzerMadsen Electronics (Canada), Ltd. · 1991
- This deviceK033645 Otoflex 100 Tye 1012Gn Otometrics A/S · 2004
- Descendant · cites it directly · 1 of its ownK061104 Speechlink 100 Type 1053Gn Otometrics A/S · 2006
- Descendant · cites it directly · 0 of its ownK161707 Madsen ZodiacGn Otometrics · 2016
- Descendant · 2 generations on · 0 of its ownK110286 GN Otometrics Type 1053 FreefitGn Otometrics A/S · 2011
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910247 | Zodiac 901 Middle-Ear Analyzer | Madsen Electronics (Canada), Ltd. | 1991 | — |
| 0 (this device) | K033645 | Otoflex 100 Tye 1012 | Gn Otometrics A/S | 2004 | — |
| +1 | K061104 | Speechlink 100 Type 1053 | Gn Otometrics A/S | 2006 | — |
| +1 | K161707 | Madsen Zodiac | Gn Otometrics | 2016 | — |
| +2 | K110286 | GN Otometrics Type 1053 Freefit | Gn Otometrics A/S | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 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? (3)
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 |
|---|---|---|---|
| * | K910247 | Zodiac 901 Middle-Ear AnalyzerSummary page 1…OTOflex 100 type 1012 Classification name: Auditory Impedance Tester Predicate devices OTOflex is similar to the product Zodiac 901 Middle-Ear Analyzer (K910247) but differs in three ways: handheld operation powered by batteries, measurement with 1000 Hz probe tone and wireless computer in… | 1991 |
| * | K923072 | HandtympSummary page 1…n powered by batteries, measurement with 1000 Hz probe tone and wireless computer interface. Handheld operation powered by batteries is currently performed %byHandtymp (K923072) and measurement with 1000 Hz probe tone is currently performed by GSI 2000 Middle Bar Analyzer (I(000097). Descriptidn The OTOf… | 1993 |
| * | K000097 | Gsi 2000 Middle Ear AnalyzerSummary page 1…ation powered by batteries is currently performed %byHandtymp (K923072) and measurement with 1000 Hz probe tone is currently performed by GSI 2000 Middle Bar Analyzer (I(000097). Descriptidn The OTOflex system consists of a charger unit, a handheld unit with built-in Bluetooth interface, a probe, a contr… | 2000 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All ETY devicesETY Tester, Auditory Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 OTOflex 100 type 1012 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/K033645 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033645: Otoflex 100 Tye 1012.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033645
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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