510(k) · Cleared
ClearedTinnitus Therapy System Anm T30 CR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anm Adaptive Neuromodulation GmbH · KLW Masker, Tinnitus
Cleared on Dec 16, 2011 as substantially equivalent to K043274 (Neuromonics Pty, Ltd., 2005) and 1 other predicate after an 86-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Dec 16, 2011
- Review
- 86 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K974501 (1998). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK974501 Digital Tinnitus Masking SystemPetroff Audio Technologies · 1998
- 2 generations backK030791 Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003
- 1 generation backK043274 Neuromonics Tinnitus TreatmentNeuromonics Pty, Ltd. · 2005
- This deviceK112752 Tinnitus Therapy System Anm T30 CRAnm Adaptive Neuromodulation GmbH · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K974501 | Digital Tinnitus Masking System | Petroff Audio Technologies | 1998 | — |
| −2 | K030791 | Anmp (Acoustic Neuro Modulation Protocol) | Tinnitech, Ltd. | 2003 | — |
| −1 | K043274 | Neuromonics Tinnitus Treatment | Neuromonics Pty, Ltd. | 2005 | — |
| 0 (this device) | K112752 | Tinnitus Therapy System Anm T30 CR | Anm Adaptive Neuromodulation GmbH | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (2)
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 |
|---|---|---|---|
| * | K043274 | Neuromonics Tinnitus TreatmentSummary page 1…tus Therapy System Product Code: KLW Device Classification: Class 11 Predicate Devices: Neuromonics Tinnitus Treatment System, K043274 (Neuromonics PlY Ltd.) TinniTech ANMP System, K030791 (Tinnitech… | 2005 |
| * | K030791 | Anmp (Acoustic Neuro Modulation Protocol)Summary page 1…Neuromonics Tinnitus Treatment System, K043274 (Neuromonics PlY Ltd.) TinniTech ANMP System, K030791 (Tinnitech Ltd.) Device Description: The ANMVI T30 CR® isa com puter-co ntro lled system for tinnitus therapy. The therapy ispro… | 2003 |
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 4 companies; a new generation was cleared every 5.2 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K043274.
How does its category compare?
All KLW devicesKLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 ANM T30 CR® Tinnitus Therapy System is intended to provide relief from the disturbance of tinnitus while using the system, and with regular use (over several months) may provide relief to the patient when not using the system.
The ANM T30 CR® Stimulator is a patient device for home use.
The ANM T30 CR® Stimulator is fitted and programmed by a qualified healthcare professional familiar with tinnitus treatment.
Stimulation needs to be applied for several hours a day over a period of weeks or months.
The target population is adults over 18 years of age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112752 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112752: Tinnitus Therapy System Anm T30 CR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112752
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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