510(k) · Cleared
ClearedTinearity G1 (6103); Tinearity G1 Adapters x3 (6042)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Duearity AB · KLW Masker, Tinnitus
Cleared on Jun 30, 2023 as substantially equivalent to K061459 (General Hearing Instruments, Inc., 2006) after a 203-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Jun 30, 2023
- Review
- 203 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K061459 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK061459 Tranquil Tri-BteGeneral Hearing Instruments, Inc. · 2006
- This deviceK223694 Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)Duearity AB · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K061459 | Tranquil Tri-Bte | General Hearing Instruments, Inc. | 2006 | — |
| 0 (this device) | K223694 | Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) | Duearity AB | 2023 | — |
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 |
|---|---|---|---|
| * | K061459 | Tranquil Tri-BteSummary page 4…erator Classification Name: Tinnitus masker Regulation Number: 21CFR874.3400 Regulatory Class: II Product Code: KLW PREDICATE DEVICE Predicate device: Tranquil TRI-BTE, K061459 This predicate device has not been subject to a design-related recall. REFERENCE DEVICE Reference device: ADHEAR System, K172460… | 2006 |
| † | K172460 | ADHEAR System | 2018 |
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?
- Its one ancestor has no recall.
How does its category compare?
All KLW devicesKLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Tinearity G1 is intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal
head noise to provide relief for patients with normal hearing in the home healthcare environment. The device is for
prescription use only. The target population is adult population over 18 years of age.
Tinearity G1 is applied on intact skin at the mastoid bone and transfers sound through bone conduction to the cochlea.
Hearing health care professional shall be consulted for diagnosis, fitting of devices, and follow-up care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223694: Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223694
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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