KLW · Class II · 21 CFR 874.3400

FDA Product Code KLW: Masker, Tinnitus

Leading manufacturers include Starkey Laboratories, Inc., Aureliym GmbH and Goldenear Company, Inc..

76
Total
76
Cleared
113d
Avg days
1977
Since
Declining activity - 0 submissions in the last 2 years vs 4 in the prior period

FDA 510(k) Cleared Masker, Tinnitus Devices (Product Code KLW)

76 devices
1–24 of 76
Cleared Feb 27, 2024
Peace N Quiet (0.7.0)
K233435
Pnq Health
Ear, Nose, Throat · 137d
Cleared Jun 30, 2023
Tinearity G1 (6103)
K223694
Duearity AB
Ear, Nose, Throat · 203d
Cleared Feb 01, 2023
Tinnitogram Signal Generator
K221168
Goldenear Company, Inc.
Ear, Nose, Throat · 285d
Cleared Jan 04, 2023
SilentCloud
K221125
Aureliym GmbH
Ear, Nose, Throat · 261d
Cleared Jun 19, 2020
Multiflex Tinnitus Technology
K201370
Starkey Laboratories, Inc.
Ear, Nose, Throat · 28d

About Product Code KLW - Regulatory Context

510(k) Submission Activity

76 total 510(k) submissions under product code KLW since 1977, with 76 receiving FDA clearance (average review time: 113 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 4 in the prior period.

KLW devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →