FDA product code KLW: Masker, Tinnitus
KLW is the FDA product code for masker, tinnitus. It is a Class II device, regulated under 21 CFR 874.3400 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 78 510(k) submissions under KLW, 6 in the last five years, from 56 different applicants. The average 510(k) review took 114 days (median 89); 141 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Masker, Tinnitus |
| Device class | Class II |
| Regulation | 21 CFR 874.3400 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KLW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 184 |
| 2018 | 2 | 152 |
| 2020 | 2 | 56 |
| 2023 | 3 | 250 |
| 2024 | 1 | 137 |
| 2026 | 2 | 145 |
Compare with all 510(k) review times · Search every KLW clearance
Top KLW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Starkey Laboratories, Inc. | 9 | 2020-06-19 |
| GN Hearing A/S | 3 | 2020-02-20 |
| Gn Resound A/S | 3 | 2015-05-14 |
| Audifon-USA, Inc. | 3 | 2013-11-21 |
| Siemens Hearing Instruments, Inc. | 3 | 2001-06-07 |
51 more applicants have KLW clearances. See the full list in Caduvo.
Most recent KLW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260413 | Levo Medical Corporation | Levo Gen 2 Tinnitus Therapy System | 2026-08-13 | 185 |
| K260614 | Sivantos GmbH | Tinnitus Therapy | 2026-06-10 | 105 |
| K233435 | Pnq Health | Peace N Quiet (0.7.0) | 2024-02-27 | 137 |
| K223694 | Duearity AB | Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) | 2023-06-30 | 203 |
| K221168 | Goldenear Company, Inc. | Tinnitogram Signal Generator | 2023-02-01 | 285 |
Recalls for KLW devices
openFDA lists no recalls for product code KLW.
Frequently asked questions
What is FDA product code KLW?
KLW is the FDA product code for masker, tinnitus. It is a Class II device, regulated under 21 CFR 874.3400 and reviewed by the Ear, Nose and Throat panel.
What device class is KLW?
Class II, regulation 21 CFR 874.3400. Typical premarket route: 510(k).
How long does a 510(k) take for product code KLW?
Across 78 cleared submissions the average was 114 days from receipt to decision (median 89).
Which companies have the most KLW clearances?
Starkey Laboratories, Inc. (9); GN Hearing A/S (3); Gn Resound A/S (3); Audifon-USA, Inc. (3); Siemens Hearing Instruments, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code KLW
- Run a recall and safety report across every KLW manufacturer
- Watch product code KLW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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