510(k) · Cleared
ClearedUltraquiet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sound Technique System, LLC · KLW Masker, Tinnitus
Cleared on Jul 13, 2002 as substantially equivalent to K003559 (Siemens Hearing Instruments, Inc., 2001) and 2 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Jul 13, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K940667 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK940667 Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing AidStarkey Laboratories, Inc. · 1994
- 1 generation backK964216 Starkey TM-3, TM-5 High Frequency Tinnitus MaskerStarkey Laboratories, Inc. · 1996
- This deviceK021202 UltraquietSound Technique System, LLC · 2002
- Descendant · cites it directly · 0 of its ownK070648 The Inhibitor, Model 001Melmedtronics, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K070648The Inhibitor, Model 001Melmedtronics, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940667 | Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing Aid | Starkey Laboratories, Inc. | 1994 | — |
| −1 | K964216 | Starkey TM-3, TM-5 High Frequency Tinnitus Masker | Starkey Laboratories, Inc. | 1996 | — |
| 0 (this device) | K021202 | Ultraquiet | Sound Technique System, LLC | 2002 | — |
| +1 | K070648 | The Inhibitor, Model 001 | Melmedtronics, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003559 | Tci (Tinnitus Control Instrument)Summary page 2…ly equivalent to other legally marketed tinnitus maskers. Specifically, the UltraQuietTMdevice is substantially equivalent to Siemens' Tinnitus Control Instrument (TCI) (K003559), ADM Tronics' Aurex-3 Tinnitus Masker (K9817040), Starkey Laboratories' Starkey TM-3, TM-5 High Frequency Tinnitus Masker (K9642… | 2001 |
| * | K981704 | AUREX-3Summary page 2…9 Sound Technique Systems \\\DC - 6848314 - #E08758 v6 Predicate Devices KO03559 Siemens TCI Tinnitus Control Instrument K981704 ADM Tronics Aurex-3 tinnitus masker K964216 Starkey TM-3, TM-5 High Frequency Tinnitus Masker K… | 1998 |
| * | K964216 | Starkey TM-3, TM-5 High Frequency Tinnitus MaskerSummary page 2…08758 v6 Predicate Devices KO03559 Siemens TCI Tinnitus Control Instrument K981704 ADM Tronics Aurex-3 tinnitus masker K964216 Starkey TM-3, TM-5 High Frequency Tinnitus Masker K982451 TTC's GHI-T & TN3-T-T tinnitus masker… | 1996 |
| Kept off the family tree | K982452 | Tinnitus Treatment Centers' TTC GHI-T and TTC TN3-T-T devices Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2…Masker (K9817040), Starkey Laboratories' Starkey TM-3, TM-5 High Frequency Tinnitus Masker (K964216), and the Tinnitus Treatment Centers' TTCGHI- and TTCTN3-T-T devices (K982452). UltraQuietTMhas the same general intended use, similar principles of operation, and similar technological charac… |
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 |
|---|---|---|---|
| K070648 | The Inhibitor, Model 001 | 2007 | 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 8 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K070648 (Melmedtronics, Inc., 2007) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K003559.
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?
The UltraQuietTM device is intended for use in the treatment and control of tinnitus. It consists of a low-level amplifier that converts pre-recorded sound into bone-conducted masking noise that is applied to the mastoid region of the head through a behind-the-ear transducer. The UltraQuietTM device produces sound of sufficient intensity and bandwidth to mask tinnitus. This device is used in conjunction with diagnosis and therapy by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis of tinnitus and subsequent rehabilitation therapy. UltraQuietTM is indicated for the treatment of tinnitus in individuals over 18 years of age that report tinnitus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021202 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021202: Ultraquiet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021202
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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