510(k) · Cleared
ClearedLevo Tinnitus Masking Software Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Otoharmonics Corp · KLW Masker, Tinnitus
Cleared on Jul 18, 2014 as substantially equivalent to K111293 (Soundcure, Inc., 2011) after a 107-day review. Its family tree reaches back 5 generations to 1998. 1 later device descends from it.
- Decided
- Jul 18, 2014
- Review
- 107 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K974501 (1998). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK974501 Digital Tinnitus Masking SystemPetroff Audio Technologies · 1998
- 4 generations backK030791 Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003
- 3 generations backK040330 QuiescenceSpectral Visualization & Development, Inc. · 2004
- 2 generations backK073636 Tinnitus Sound Generator ModuleGn Resound A/S · 2008
- 1 generation backK111293 Soundcure Serenade Tinnitus Treatment SystemSoundcure, Inc. · 2011
- This deviceK140845 Levo Tinnitus Masking Software DeviceOtoharmonics Corp · 2014
- Descendant · cites it directly · 0 of its ownK163094 TinniLogic Mobile Tinnitus Management DeviceJiangsu Betterlife Medical Co., Ltd. · 2017
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −5 | K974501 | Digital Tinnitus Masking System | Petroff Audio Technologies | 1998 | — |
| −4 | K030791 | Anmp (Acoustic Neuro Modulation Protocol) | Tinnitech, Ltd. | 2003 | — |
| −3 | K040330 | Quiescence | Spectral Visualization & Development, Inc. | 2004 | — |
| −2 | K073636 | Tinnitus Sound Generator Module | Gn Resound A/S | 2008 | — |
| −1 | K111293 | Soundcure Serenade Tinnitus Treatment System | Soundcure, Inc. | 2011 | — |
| 0 (this device) | K140845 | Levo Tinnitus Masking Software Device | Otoharmonics Corp | 2014 | — |
| +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 |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K111293 | Soundcure Serenade Tinnitus Treatment SystemSummary page 1…Classification Tinnitus Masker Device, 21 CFR 874.3400 (Product Code KLW), Class 11 Predicate Devices SoundCure, Inc.'s Serenade Tinnitus Treatment System (K1 11293) Intended Use I Indications for Use The Levo System is indicated for use in the temporary relief of tinnitus symptoms. The… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163094 | TinniLogic Mobile Tinnitus Management Device | 2017 | 0 |
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 16 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K163094 (Jiangsu Betterlife Medical Co., Ltd., 2017) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K111293.
How does its category compare?
All KLW devicesKLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 LEVO Tinnitus Masking Device 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 tinnhtus 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/K140845 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140845: Levo Tinnitus Masking Software Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140845
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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