510(k) · Cleared
ClearedTITAN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interacoustics A/S · ETY Tester, Auditory Impedance
Cleared on Nov 29, 2012 as substantially equivalent to K083861 (Interacoustics AS, 2009) and 1 other predicate after a 157-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Nov 29, 2012
- Review
- 157 days
- Class
- Class II
- Product code
- ETY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K994254 (2000). 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 | K994254 | Interacoustics AT235 Impedance Audiometer | International Distributors of Electronics For Medi | 2000 | — |
| −1 | K083861 | Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan IMP440, IMP440… | Interacoustics AS | 2009 | — |
| 0 (this device) | K121847 | TITAN | Interacoustics A/S | 2012 | — |
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 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 |
|---|---|---|---|
| * | K083861 | Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan IMP440, IMP440 Module…Summary page 1…lass 11 SUBSTANTIAL EQUIVALENCE (TITAN WITH 1MP440) Predicate Device Titan with IMP440 Manufacturer Interacoustics 510(k) No. K083861 Date Cleared 04/09/2006 SUBSTANTIAL EQUIVALENCE (MIMOSA HEARID) Predicate Device HEARID WIDEBAND MIDDL… | 2009 |
| * | K053216 | Hearid Wideband Middle Ear Power AnalyzerSummary page 1…LENCE (MIMOSA HEARID) Predicate Device HEARID WIDEBAND MIDDLE EAR POWER ANALYZER Manufacturer MIMOSA ACOUSTICS, INC 510(k) No. K053216 Date Cleared 02/10/2006 Section 05 p. 2 -il ntrcusi… | 2006 |
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 12 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K083861.
How does its category compare?
All ETY devicesETY Tester, Auditory Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustic reflexes. The Titan Impedance System measures various acoustic properties of the ear, namely power reflectance, power absorption, transmittance, reflectance group delay…
Read the full statement (149 words)
The Titan Impedance System is an electroacoustic test instrument that produces
controlled levels of test tones and signals intended for use in conduction diagnostic
hearing evaluations and assisting in the diagnosis of possible otologic disorders. It
features tympanometry and acoustic reflexes.
The Titan Impedance System measures various acoustic properties of the ear, namely
power reflectance, power absorption, transmittance, reflectance group delay, complex
acoustic impedance and admittance, and equivalent ear canal volume. These measures
allow the evaluation of the functional condition of the middle and outer ear.
The Titan Impedance System is suitable for all populations including new-born infants.
The Titan Impedance System is to be used by trained personnel only such as audiologists,
ENT surgeons, doctors, hearing healthcare professionals or personnel with a similar level
of education. The device should not be used without the necessary knowledge and training
to understand its use and how results should be interpreted.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121847 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121847: TITAN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121847
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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