DeviceClearance

Product code KLW— Ear, Nose, Throat

Tinnitus Sound Generator Module

Classification name
Masker, Tinnitus
Device class
Class 2
Regulation
21 CFR 874.3400
Advisory panel
Ear, Nose, Throat
Total cleared
78
First cleared
Most recent

Market context for product code KLW

FDA has cleared 78 devices under product code KLW between 1977 and 2026, filed by 56 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code KLW

Recent clearances under product code KLW

Data sourced from openFDA. This site is unofficial and independent of the FDA.