510(k) · Cleared
ClearedThe Inhibitor, Model 001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Melmedtronics, Inc. · KLW Masker, Tinnitus
Cleared on Jun 29, 2007 as substantially equivalent to K013253 (Hearing Innovations, Inc., 2002) and 3 other predicates after a 113-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Jun 29, 2007
- Review
- 113 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K940667 (1994). 9 ancestors in all, the oldest K791790 (1979). No later device cites it as a predicate yet.
- Root · 3 generations backK940667 Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing AidStarkey Laboratories, Inc. · 1994
- 2 generations backK963838 Starkey TM Air Conduction Tinnitus MaskerStarkey Laboratories, Inc. · 1996
- 1 generation backK013253 Hisonic-TRD Tinnitus Relief DeviceHearing Innovations, Inc. · 2002
- This deviceK070648 The Inhibitor, Model 001Melmedtronics, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940667 | Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing Aid | Starkey Laboratories, Inc. | 1994 | — |
| −2 | K963838 | Starkey TM Air Conduction Tinnitus Masker | Starkey Laboratories, Inc. | 1996 | — |
| −1 | K013253 | Hisonic-TRD Tinnitus Relief Device | Hearing Innovations, Inc. | 2002 | — |
| 0 (this device) | K070648 | The Inhibitor, Model 001 | Melmedtronics, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013253 | Hisonic-TRD Tinnitus Relief DeviceSummary page 1…77KLW Performance Standards: Substantial Equivalence to the following predicate devices: K013253 (Hearing Innovations HiSonic TDR Tinnitus Relief Device) K021202 (Sound Technique… | 2002 |
| * | K021202 | UltraquietSummary page 1…edicate devices: K013253 (Hearing Innovations HiSonic TDR Tinnitus Relief Device) K021202 (Sound Technique Systems, LLC: Ultra Quiet) K964216 (Starkey TM-3, TM-5 High Frequency Ti… | 2002 |
| * | K964216 | Starkey TM-3, TM-5 High Frequency Tinnitus MaskerSummary page 1…ic TDR Tinnitus Relief Device) K021202 (Sound Technique Systems, LLC: Ultra Quiet) K964216 (Starkey TM-3, TM-5 High Frequency Tinnitus Masker, Starkey Labs) K003559 (Siemens… | 1996 |
| * | K003559 | Tci (Tinnitus Control Instrument)Summary page 1…a Quiet) K964216 (Starkey TM-3, TM-5 High Frequency Tinnitus Masker, Starkey Labs) K003559 (Siemens TCI Tinnitus Control Instrument) Description of Device The InhibitorTM is a hand-held device that emits a ultra… | 2001 |
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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All KLW devicesKLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The device is intended to be used for the temporary relief of tinnitus. The unit emits an ultrasonic signal that masks or inhibits the sound of tinnitus in many afflicted individuals. The tip of the device is placed firmly against the bone behind the ear and held in place until the device goes off (60-90 seconds). This is a medical device and should only be used with the advice of a physician, audiologist or licensed hearing aid dispenser. Only adults 18…
Read the full statement (210 words)
The device is intended to be used for the temporary relief of tinnitus. The unit emits an ultrasonic signal that masks or inhibits the sound of tinnitus in many afflicted individuals. The tip of the device is placed firmly against the bone behind the ear and held in place until the device goes off (60-90 seconds).
This is a medical device and should only be used with the advice of a physician, audiologist or licensed hearing aid dispenser. Only adults 18 years of age and older should be dispensed an instrument. The following precautions should also be followed:
DISCONTINUE USE (IF CURENTLY USING) OR DO NOT BEGIN TO USE IF:
1. You have a pacemaker.
2. You are pregnant.
3. You have any metal bonded teeth retainers.
4. You have any metal implants in your head or neck.
5. You are prone to migraines or headaches.
6. You have had any recent surgeries (last six months) and are still recovering.
7. You have any thrombosis.
8. Your tinnitus becomes louder.
9. You get a headache after using the device.
10. You become nauseous after using the device.
i1. You notice any discomfort at the treatment site.
12. You have any medical condition that your physician would advise against its use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070648: The Inhibitor, Model 001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070648
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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