510(k) · Cleared
ClearedTST - Suppressor Model #1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurosim Limited · KLW Masker, Tinnitus
Cleared on May 21, 2002 after a 183-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 21, 2002
- Review
- 183 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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 TST Suppressor 1000 device is selected sound tracks delivered to the ear by a standard digital audio player and using an air-conduction earpiece or headphone type transducers. The TST Suppressor 1000 is indicated for adult (over 18 years of age) Tinnitus sufferers who experience relief of their Tinnitus symptoms when using the device and where such people have fair to excellent hearing in the frequency range 100 Hz to 8,000 Hz (8 kHz), and there is…
Read the full statement (134 words)
The TST Suppressor 1000 device is selected sound tracks delivered to the ear by a standard digital audio player and using an air-conduction earpiece or headphone type transducers. The TST Suppressor 1000 is indicated for adult (over 18 years of age) Tinnitus sufferers who experience relief of their Tinnitus symptoms when using the device and where such people have fair to excellent hearing in the frequency range 100 Hz to 8,000 Hz (8 kHz), and there is no more than 35 dB loss in the affected ear in that frequency range and where their Tinnitus is unilateral or bilateral.
The TST Suppressor 1000 is for home use.
Each TST Suppressor 1000 device may be used to suppress the symptoms of tinnitus when operated on the digital audio player, using commercially available earphones or headphones.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013827 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013827: TST - Suppressor Model #1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013827
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026