510(k) · Cleared
ClearedREVE134
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kw Ear Lab, Inc. · KLW Masker, Tinnitus
Cleared on Oct 9, 2015 as substantially equivalent to K133308 (Oticon A/S, 2014) and 1 other predicate after a 106-day review. Its family tree reaches back 7 generations to 1998. 1 later device descends from it.
- Decided
- Oct 9, 2015
- Review
- 106 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K974501 (1998). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK974501 Digital Tinnitus Masking SystemPetroff Audio Technologies · 1998
- 6 generations backK030791 Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003
- 5 generations backK040330 QuiescenceSpectral Visualization & Development, Inc. · 2004
- 4 generations backK073636 Tinnitus Sound Generator ModuleGn Resound A/S · 2008
- 3 generations backK110932 Tinnitus Sound Generator ModuleGn Resound A/S · 2011
- 2 generations backK123450 Phonak Tinnitus BalancePhonak, LLC · 2013
- 1 generation backK133308 Tinnitus SoundsupportOticon A/S · 2014
- This deviceK151719 REVE134Kw Ear Lab, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK221168 Tinnitogram Signal GeneratorGoldenear Company, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K221168Tinnitogram Signal GeneratorGoldenear Company, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K974501 | Digital Tinnitus Masking System | Petroff Audio Technologies | 1998 | — |
| −6 | K030791 | Anmp (Acoustic Neuro Modulation Protocol) | Tinnitech, Ltd. | 2003 | — |
| −5 | K040330 | Quiescence | Spectral Visualization & Development, Inc. | 2004 | — |
| −4 | K073636 | Tinnitus Sound Generator Module | Gn Resound A/S | 2008 | — |
| −3 | K110932 | Tinnitus Sound Generator Module | Gn Resound A/S | 2011 | — |
| −2 | K123450 | Phonak Tinnitus Balance | Phonak, LLC | 2013 | — |
| −1 | K133308 | Tinnitus Soundsupport | Oticon A/S | 2014 | — |
| 0 (this device) | K151719 | REVE134 | Kw Ear Lab, Inc. | 2015 | — |
| +1 | K221168 | Tinnitogram Signal Generator | Goldenear Company, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K133308 | Tinnitus SoundsupportSummary page 4…2015 Device Name: REVE134 Device Class: Class II Classification Name: Tinnitus Masker Classification Regulation: 21 C.FR. 874.3400 Product Code KLW Predicate Devices: K 133308 Tinnitus SoundSupport, Oticon K 110932 Tinnitus Sound Generator, GN Resound Intended Use / Indication for Use: Technological Ch… | 2014 |
| * | K110932 | Tinnitus Sound Generator ModuleSummary page 4…Class II Classification Name: Tinnitus Masker Classification Regulation: 21 C.FR. 874.3400 Product Code KLW Predicate Devices: K 133308 Tinnitus SoundSupport, Oticon K 110932 Tinnitus Sound Generator, GN Resound Intended Use / Indication for Use: Technological Characteristics: REVE134 is a sound gene… | 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 |
|---|---|---|---|
| K221168 | Tinnitogram Signal Generator | 2023 | 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 17 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K221168 (Goldenear Company, Inc., 2023) has gone furthest, with 0 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. 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?
REVE134 is a sound generating software used in a Tinnitus Management Program designed to provide temporary relief for people experiencing tinnitus symptoms. It is intended primarily for adults over 18 years of age, but may also be used for children 5 years of age or older. REVE134 is for use by hearing healthcare professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. A hearing healthcare professional should recommend that a patient listen to the REVE134 signal for 30 minutes twice a day at the barely audible level (minimally detectable level).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151719: REVE134.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151719
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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