510(k) · Cleared
ClearedSerenity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sanuthera, Inc. · KLW Masker, Tinnitus
Cleared on Jul 27, 2015 as substantially equivalent to K130494 (Unitron Hearing, 2013) after a 203-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- Jul 27, 2015
- Review
- 203 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K974501 (1998). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK974501 Digital Tinnitus Masking SystemPetroff Audio Technologies · 1998
- 5 generations backK030791 Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003
- 4 generations backK040330 QuiescenceSpectral Visualization & Development, Inc. · 2004
- 3 generations backK073636 Tinnitus Sound Generator ModuleGn Resound A/S · 2008
- 2 generations backK110932 Tinnitus Sound Generator ModuleGn Resound A/S · 2011
- 1 generation backK130494 Unitron Tinnitus Masker FeatureUnitron Hearing · 2013
- This deviceK150014 SerenitySanuthera, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K974501 | Digital Tinnitus Masking System | Petroff Audio Technologies | 1998 | — |
| −5 | K030791 | Anmp (Acoustic Neuro Modulation Protocol) | Tinnitech, Ltd. | 2003 | — |
| −4 | K040330 | Quiescence | Spectral Visualization & Development, Inc. | 2004 | — |
| −3 | K073636 | Tinnitus Sound Generator Module | Gn Resound A/S | 2008 | — |
| −2 | K110932 | Tinnitus Sound Generator Module | Gn Resound A/S | 2011 | — |
| −1 | K130494 | Unitron Tinnitus Masker Feature | Unitron Hearing | 2013 | — |
| 0 (this device) | K150014 | Serenity | Sanuthera, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 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 |
|---|---|---|---|
| * | K130494 | Unitron Tinnitus Masker FeatureSummary page 4…gulatory Class: Class II Product Code: KLW III. PREDICATE DEVICE Predicate: Unitron Tinnitus Masker Feature, K130494, with market clearance date of May 7, 2013 IV. DEVICE DESCRIPTION Description:… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All KLW devicesKLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Sanuthera’s Serenity device is indicated to provide a mean of sound enrichment therapy that is programmed by a hearing health care professional familiar with diagnosis and management of tinnitus as part of a personalized tinnitus management program to provide temporary relief from the tinnitus symptoms.
The target population is primarily the adult population over 18 years of age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150014 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150014: Serenity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150014
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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