510(k) · Cleared
ClearedTITAN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interacoustics A/S · GWJ Stimulator, Auditory, Evoked Response
Cleared on May 5, 2011 as substantially equivalent to K060539 (Interacoustics A/S, Assens, 2006) and 1 other predicate after a 133-day review. Its family tree reaches back 1 generation to 2006. 5 later devices descend from it.
- Decided
- May 5, 2011
- Review
- 133 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K060539 (2006). 2 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK060539 DPOAE20 , EclipseInteracoustics A/S, Assens · 2006
- This deviceK103760 TITANInteracoustics A/S · 2011
- Descendant · cites it directly · 4 of its ownK130795 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 5 of 5 · See all- K130795TITANInteracoustics A/S · 2013 · cites it directly4descendants
- K171506EasyscreenMaico Diagnostics GmbH · 2017 · cites it directly1descendant
- K191372LyraInteracoustics A/S · 2019 · cites it directly0descendants
- K173567SeraInteracoustics A/S · 2018 · 2 generations on0descendants
- K172403GSI NovusGrason-Stadler, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060539 | DPOAE20 , Eclipse | Interacoustics A/S, Assens | 2006 | — |
| 0 (this device) | K103760 | TITAN | Interacoustics A/S | 2011 | — |
| +1 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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 GWJ? 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 GWJ device
- #1 K242954 Integrity V500 (Integrity, Integrity with VEMP)score 10.0 · 6 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 |
|---|---|---|---|
| * | K060539 | DPOAE20 , EclipseSummary page 1…SUBSTANTIAL EQUIVALENCE (TITAN WITH DPOAE44O) Predicate Device DPOAE20 (Eclipse) Manufacturer Interacoustics 510(k) No. K060539 Date Cleared 05/30/2006 SUBSTANTIAL EQUIVALENCE (TITAN WITH A6R15440) Predicate Device Maico MB 11… | 2006 |
| * | K082035 | Maico MB 11 with Beraphone ProbeSummary page 1…05/30/2006 SUBSTANTIAL EQUIVALENCE (TITAN WITH A6R15440) Predicate Device Maico MB 11 Manufacturer MAI CO 510(k) No. K(082035 Date Cleared 01/29/2009 Section05 p. 2 -10 neaosi" === Page… | 2009 |
What descends from it? (5)
4 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 GWJ devicesGWJ Stimulator, Auditory, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · GWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GWJ
111in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWJ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWJ
1in 2025
MAUDE reports naming product code GWJ, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 64 | 1 | 0 |
| 2009 | 4 | 111 | 0 | 0 |
| 2010 | 1 | — | 1 | 2 |
| 2011 | 2 | — | 0 | 5 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 43 |
| 2018 | 0 | — | 0 | 24 |
| 2019 | 0 | — | 1 | 5 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 2 | — | 0 | 7 |
| 2025 | 0 | — | 1 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Titan with DPOAE44O is intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. The target population for Titan with DPOAE44O includes all ages.
The Titan with ABRIS44O is intended for use in the audiologic evaluation and documentation of ear and nerve disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem.The target population for Titan with ABRIS440 is newborns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103760 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103760: TITAN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103760
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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