510(k) · Cleared
ClearedSoundcure Serenade Tinnitus Treatment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Soundcure, Inc. · KLW Masker, Tinnitus
Cleared on Aug 24, 2011 as substantially equivalent to K073636 (Gn Resound A/S, 2008) after a 110-day review. Its family tree reaches back 4 generations to 1998. 6 later devices descend from it.
- Decided
- Aug 24, 2011
- Review
- 110 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K974501 (1998). 6 ancestors in all. 6 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK974501 Digital Tinnitus Masking SystemPetroff Audio Technologies · 1998
- 3 generations backK030791 Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003
- 2 generations backK040330 QuiescenceSpectral Visualization & Development, Inc. · 2004
- 1 generation backK073636 Tinnitus Sound Generator ModuleGn Resound A/S · 2008
- This deviceK111293 Soundcure Serenade Tinnitus Treatment SystemSoundcure, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK150065 SoundCure Serenade Tinnitus Treatment SystemSoundcure, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK161562 Sound Options Tinnitus TreatmentSound Options Tinnitus Treatments, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK140845 Levo Tinnitus Masking Software DeviceOtoharmonics Corp · 2014
- Descendant · 2 generations on · 0 of its ownK233435 Peace N Quiet (0.7.0)Pnq Health · 2024
- Descendant · cites it directly · 0 of its ownK163094 TinniLogic Mobile Tinnitus Management DeviceJiangsu Betterlife Medical Co., Ltd. · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K150065SoundCure Serenade Tinnitus Treatment SystemSoundcure, Inc. · 2015 · cites it directly2descendants
- K161562Sound Options Tinnitus TreatmentSound Options Tinnitus Treatments, Inc. · 2016 · cites it directly1descendant
- K140845Levo Tinnitus Masking Software DeviceOtoharmonics Corp · 2014 · cites it directly1descendant
- K233435Peace N Quiet (0.7.0)Pnq Health · 2024 · 2 generations on0descendants
- K163094TinniLogic Mobile Tinnitus Management DeviceJiangsu Betterlife Medical Co., Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K974501 | Digital Tinnitus Masking System | Petroff Audio Technologies | 1998 | — |
| −3 | K030791 | Anmp (Acoustic Neuro Modulation Protocol) | Tinnitech, Ltd. | 2003 | — |
| −2 | K040330 | Quiescence | Spectral Visualization & Development, Inc. | 2004 | — |
| −1 | K073636 | Tinnitus Sound Generator Module | Gn Resound A/S | 2008 | — |
| 0 (this device) | K111293 | Soundcure Serenade Tinnitus Treatment System | Soundcure, Inc. | 2011 | — |
| +1 | K150065 | SoundCure Serenade Tinnitus Treatment System | Soundcure, Inc. | 2015 | — |
| +1 | K161562 | Sound Options Tinnitus Treatment | Sound Options Tinnitus Treatments, Inc. | 2016 | — |
| +1 | K140845 | Levo Tinnitus Masking Software Device | Otoharmonics Corp | 2014 | — |
| +2 | K233435 | Peace N Quiet (0.7.0) | Pnq Health | 2024 | — |
| +1 | K163094 | TinniLogic Mobile Tinnitus Management Device | Jiangsu Betterlife Medical Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2024 | 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 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? (1)
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 |
|---|---|---|---|
| * | K073636 | Tinnitus Sound Generator ModuleSummary page 1…es The SoundCure TM Serenade TM Tinnitus Treatment System is substantially equivalent to the GN Resound A/S Tinnitus Sound Generator Module cleared under K073636. Appendix A, Page 1 of 5 SoundCure, Inc.… | 2008 |
What descends from it? (6)
5 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 13 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K150065 (Soundcure, Inc., 2015) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K073636.
How does its category compare?
All KLW devicesKLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The SoundCure Serenade Tinnitus Treatment System is indicated for use in the temporary relief of tinnitus symptoms. The device is a tool to generate customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is adults (18 years or older).
This is a medical device and should only be used with the advice of a physician, audiologist or other hearing healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111293 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111293: Soundcure Serenade Tinnitus Treatment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111293
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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