510(k) · Cleared
ClearedTITAN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interacoustics A/S · EWO Audiometer
Cleared on Jun 20, 2013 as substantially equivalent to K103760 (Interacoustics A/S, 2011) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 2006. 4 later devices descend from it.
- Decided
- Jun 20, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K060539 (2006). 4 ancestors in all, the oldest K052562 (2005). 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK060539 DPOAE20 , EclipseInteracoustics A/S, Assens · 2006
- 1 generation backK103760 TITANInteracoustics A/S · 2011
- This deviceK130795 TITANInteracoustics A/S · 2013
- Descendant · cites it directly · 1 of its ownK171506 EasyscreenMaico Diagnostics GmbH · 2017
- Descendant · cites it directly · 0 of its ownK191372 LyraInteracoustics A/S · 2019
- Descendant · 2 generations on · 0 of its ownK173567 SeraInteracoustics A/S · 2018
- Descendant · cites it directly · 0 of its ownK172403 GSI NovusGrason-Stadler, Inc. · 2017
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K060539 | DPOAE20 , Eclipse | Interacoustics A/S, Assens | 2006 | — |
| −1 | K103760 | TITAN | Interacoustics A/S | 2011 | — |
| 0 (this device) | K130795 | TITAN | Interacoustics A/S | 2013 | — |
| +1 | K171506 | Easyscreen | Maico Diagnostics GmbH | 2017 | — |
| +1 | K191372 | Lyra | Interacoustics A/S | 2019 | — |
| +2 | K173567 | Sera | Interacoustics A/S | 2018 | — |
| +1 | K172403 | GSI Novus | Grason-Stadler, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 EWO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EWO device
- #1 K234095 OtoNova/OtoNova Proscore 9.3 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K103760 | TITANSummary page 1…Affairs Marts 21 2013 Titan Audiometer Otoacoustic emission device EWO Ear Nose & Throat Class Il (According to 21CFR874.1050) Titan with DPOAE440 Interacoustics K103760 05/05/2011 Eclipse with TEQAE25 Interacoustics K052562 12/23/2005 P\ AN /4 Interacoustics Titan, TEOAE440 P… | 2011 |
| * | K052562 | Eclipse (Cabinet Name), TEOAE25, EP15, or the Combination of Systems.Summary page 1…ission device EWO Ear Nose & Throat Class Il (According to 21CFR874.1050) Titan with DPOAE440 Interacoustics K103760 05/05/2011 Eclipse with TEQAE25 Interacoustics K052562 12/23/2005 P\ AN /4 Interacoustics Titan, TEOAE440 Premarket Notification Submission 510(k) Device Descripti… | 2005 |
What descends from it? (4)
3 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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K171506 (Maico Diagnostics GmbH, 2017) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K103760.
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · EWO
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · EWO
173in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EWO
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EWO
13in 2025
MAUDE reports naming product code EWO, 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 | 5 | 69 | 0 | 1 |
| 2008 | 1 | — | 1 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 3 | 151 | 0 | 2 |
| 2012 | 4 | 137 | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 173 | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 1 | — | 4 | 3 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Titan with TEOAE440 is intended for use in the audiologic evaluation and documentation of ear disorders using Transient Evoked Otoacoustic Emissions. The target population for Titan with TEOAE440 includes all ages.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130795: TITAN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130795
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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