510(k) · Cleared
ClearedCustom Tci (Tinnitus Control Instrument)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Hearing Instruments, Inc. · KLW Masker, Tinnitus
Cleared on Jun 7, 2001 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 32 later devices descend from it.
- Decided
- Jun 7, 2001
- Review
- 34 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 0
32 later devices descend from it, 2 citing it directly.
- This deviceK011364 Custom Tci (Tinnitus Control Instrument)Siemens Hearing Instruments, Inc. · 2001
- Descendant · cites it directly · 31 of its ownK030791 Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003
- Descendant · 2 generations on · 23 of its ownK040330 QuiescenceSpectral Visualization & Development, Inc. · 2004
- Descendant · 3 generations on · 22 of its ownK073636 Tinnitus Sound Generator ModuleGn Resound A/S · 2008
- Descendant · 4 generations on · 13 of its ownK110932 Tinnitus Sound Generator ModuleGn Resound A/S · 2011
- Descendant · cites it directly · 7 of its ownK043274 Neuromonics Tinnitus TreatmentNeuromonics Pty, Ltd. · 2005
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K030791Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003 · cites it directly31descendants
- K040330QuiescenceSpectral Visualization & Development, Inc. · 2004 · 2 generations on23descendants
- K073636Tinnitus Sound Generator ModuleGn Resound A/S · 2008 · 3 generations on22descendants
- K110932Tinnitus Sound Generator ModuleGn Resound A/S · 2011 · 4 generations on13descendants
- K043274Neuromonics Tinnitus TreatmentNeuromonics Pty, Ltd. · 2005 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011364 | Custom Tci (Tinnitus Control Instrument) | Siemens Hearing Instruments, Inc. | 2001 | — |
| +1 | K030791 | Anmp (Acoustic Neuro Modulation Protocol) | Tinnitech, Ltd. | 2003 | — |
| +2 | K040330 | Quiescence | Spectral Visualization & Development, Inc. | 2004 | — |
| +3 | K073636 | Tinnitus Sound Generator Module | Gn Resound A/S | 2008 | — |
| +4 | K110932 | Tinnitus Sound Generator Module | Gn Resound A/S | 2011 | — |
| +1 | K043274 | Neuromonics Tinnitus Treatment | Neuromonics Pty, Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KLW? 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 KLW device
- #1 K260413 Levo Gen 2 Tinnitus Therapy Systemscore 11.8 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (32)
See all 322 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?
- Of its descendants, K030791 (Tinnitech, Ltd., 2003) has gone furthest, with 31 descendants of its own.
How does its category compare?
All KLW devicesKLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KLW
261in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KLW
No recall names KLW since 2007.
Adverse event reports per year · KLW
4in 2015
MAUDE reports naming product code KLW, 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 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 4 | 58 | 0 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 4 | 150 | 0 | 0 |
| 2014 | 4 | 164 | 0 | 0 |
| 2015 | 4 | 107 | 0 | 4 |
| 2016 | 3 | 114 | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 3 | 261 | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K011364 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011364: Custom Tci (Tinnitus Control Instrument).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011364
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026