510(k) · Cleared
ClearedQuiescence
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectral Visualization & Development, Inc. · KLW Masker, Tinnitus
Cleared on Apr 12, 2004 as substantially equivalent to K030791 (Tinnitech, Ltd., 2003) after a 61-day review. Its family tree reaches back 2 generations to 1998. 23 later devices descend from it.
- Decided
- Apr 12, 2004
- Review
- 61 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K974501 (1998). 3 ancestors in all. 23 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK974501 Digital Tinnitus Masking SystemPetroff Audio Technologies · 1998
- 1 generation backK030791 Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003
- This deviceK040330 QuiescenceSpectral Visualization & Development, Inc. · 2004
- Descendant · cites it directly · 22 of its ownK073636 Tinnitus Sound Generator ModuleGn Resound A/S · 2008
- Descendant · 2 generations on · 13 of its ownK110932 Tinnitus Sound Generator ModuleGn Resound A/S · 2011
- Descendant · 2 generations on · 6 of its ownK111293 Soundcure Serenade Tinnitus Treatment SystemSoundcure, Inc. · 2011
- Descendant · 3 generations on · 3 of its ownK150171 Tinnitus Sound Generator ModuleGn Resound A/S · 2015
- Descendant · 3 generations on · 3 of its ownK123450 Phonak Tinnitus BalancePhonak, LLC · 2013
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K073636Tinnitus Sound Generator ModuleGn Resound A/S · 2008 · cites it directly22descendants
- K110932Tinnitus Sound Generator ModuleGn Resound A/S · 2011 · 2 generations on13descendants
- K111293Soundcure Serenade Tinnitus Treatment SystemSoundcure, Inc. · 2011 · 2 generations on6descendants
- K150171Tinnitus Sound Generator ModuleGn Resound A/S · 2015 · 3 generations on3descendants
- K123450Phonak Tinnitus BalancePhonak, LLC · 2013 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974501 | Digital Tinnitus Masking System | Petroff Audio Technologies | 1998 | — |
| −1 | K030791 | Anmp (Acoustic Neuro Modulation Protocol) | Tinnitech, Ltd. | 2003 | — |
| 0 (this device) | K040330 | Quiescence | Spectral Visualization & Development, Inc. | 2004 | — |
| +1 | K073636 | Tinnitus Sound Generator Module | Gn Resound A/S | 2008 | — |
| +2 | K110932 | Tinnitus Sound Generator Module | Gn Resound A/S | 2011 | — |
| +2 | K111293 | Soundcure Serenade Tinnitus Treatment System | Soundcure, Inc. | 2011 | — |
| +3 | K150171 | Tinnitus Sound Generator Module | Gn Resound A/S | 2015 | — |
| +3 | K123450 | Phonak Tinnitus Balance | Phonak, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 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), 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 |
|---|---|---|---|
| * | K030791 | Anmp (Acoustic Neuro Modulation Protocol)Summary page 1…name: Tinnitus masker Classification of Device Class 11 Product Code: KLW Marketed device to which the K03 0791 claim of substantial equivalence is TinniTech ANMP System made: 33 ===… | 2003 |
What descends from it? (23)
See all 231 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073636 | Tinnitus Sound Generator Module | 2008 | 22 |
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 6 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K073636 (Gn Resound A/S, 2008) has gone furthest, with 22 descendants of its own.
- 5 other devices also cite its predicate K030791.
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 | — |
What is it indicated for?
This software device, Quiescence™, is indicated for use by otolaryngologists, audiologists, and hearing-aid dispensers (collectively referred to as healthcare professionals) for generating custom masking sounds to mask tinnitus as part of a tinnitus management program. The target population of the device is adults (18 years and over) who report experiencing tinnitus, which may or may not be accompanied with hearing loss. Patients should receive a medical evaluation by a licensed physician who specializes in diseases of the ear to rule-out medically or surgically treatable diseases for which tinnitus is a symptom before proceeding with non-medical tinnitus management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040330 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040330: Quiescence.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040330
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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