510(k) · Cleared
ClearedInventis Middle Ear Analyzer, Flute Basic, Inventis Middle Ear Analyzer, Flute Plus, Inventis Middle Ear Analyzer, Flute
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inventis S.R.L. · ETY Tester, Auditory Impedance
Cleared on Jan 24, 2014 as substantially equivalent to K022728 (Interacoustics A/S, Assens, 2002) after a 121-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Jan 24, 2014
- Review
- 121 days
- Class
- Class II
- Product code
- ETY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K022728 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK022728 Audiotraveller, Model AA222Interacoustics A/S, Assens · 2002
- This deviceK133013 Inventis Middle Ear Analyzer, Flute Basic, Inventis Middle Ear…Inventis S.R.L. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022728 | Audiotraveller, Model AA222 | Interacoustics A/S, Assens | 2002 | — |
| 0 (this device) | K133013 | Inventis Middle Ear Analyzer, Flute Basic, Inventis Middle Ear Analyzer, Flute… | Inventis S.R.L. | 2014 | — |
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 |
|---|---|---|---|
| * | K022728 | Audiotraveller, Model AA222Summary page 2…l Equivalence Inventis Middle Ear Analyzers (Flute and Viola) represent a mo dification of the cleared device, Interacoustics Audiotraveller, Model AA222 (510(k) number: K022728). The changes are of minor nature and do not concern the main functions of the predicate device. In particular, the differences r… | 2002 |
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?
- Its one ancestor has no recall.
How does its category compare?
All ETY devicesETY Tester, Auditory Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Inventis Middle Ear Analyzers, Flute and Viola, are intended for use by trained operators in hospitals, nurseries, ENT clinics and audiology offices in conducting diagnostic hearing evaluations and assisting in diagnosis of possible otologic disorders. The Inventis Middle Ear Analyzers are intended for use on individuals six months of age or older. Flute is a tympanometer. Viola is a combination of audiometer and tympanometer, which reduces the amount of necessary equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133013 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133013: Inventis Middle Ear Analyzer, Flute Basic, Inventis Middle Ear Analyzer, Flute Plus, Inventis Middle Ear Analyzer, Flute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133013
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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