510(k) · Cleared
ClearedMaico MB 11 with Beraphone Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maico Diagnostics · GWJ Stimulator, Auditory, Evoked Response
Cleared on Jan 29, 2009 after a 196-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Jan 29, 2009
- Review
- 196 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK082035 Maico MB 11 with Beraphone ProbeMaico Diagnostics · 2009
- Descendant · cites it directly · 5 of its ownK103760 TITANInteracoustics A/S · 2011
- Descendant · 2 generations on · 4 of its ownK130795 TITANInteracoustics A/S · 2013
- Descendant · 2 generations on · 1 of its ownK171506 EasyscreenMaico Diagnostics GmbH · 2017
- Descendant · 2 generations on · 0 of its ownK191372 LyraInteracoustics A/S · 2019
- Descendant · 3 generations on · 0 of its ownK173567 SeraInteracoustics A/S · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K103760TITANInteracoustics A/S · 2011 · cites it directly5descendants
- K130795TITANInteracoustics A/S · 2013 · 2 generations on4descendants
- K171506EasyscreenMaico Diagnostics GmbH · 2017 · 2 generations on1descendant
- K191372LyraInteracoustics A/S · 2019 · 2 generations on0descendants
- K173567SeraInteracoustics A/S · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082035 | Maico MB 11 with Beraphone Probe | Maico Diagnostics | 2009 | — |
| +1 | K103760 | TITAN | Interacoustics A/S | 2011 | — |
| +2 | K130795 | TITAN | Interacoustics A/S | 2013 | — |
| +2 | K171506 | Easyscreen | Maico Diagnostics GmbH | 2017 | — |
| +2 | K191372 | Lyra | Interacoustics A/S | 2019 | — |
| +3 | K173567 | Sera | Interacoustics A/S | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103760 | TITAN | 2011 | 5 |
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?
- Of its descendants, K103760 (Interacoustics A/S, 2011) has gone furthest, with 5 descendants of its own.
How does its category compare?
All GWJ devicesGWJ Stimulator, Auditory, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Maico MB 11 with BERAphone and the MB 11 Standard are intended to generate evoked auditory brainstem response (ABR) - based measurements for newborn hearing screening, providing a PASS/REFER result. This does not require special technical skills or interpretation of the results.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K082035 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082035: Maico MB 11 with Beraphone Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082035
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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