510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KLWClass II

Masker, Tinnitus

21 CFR 874.3400 / Ear, Nose, Throat
FDA source (opens on fda.gov)

KLW is the FDA product code for Masker, Tinnitus, a class II device type, regulated under 21 CFR 874.3400. As of , FDA records hold 78 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KLW
Device name
Masker, Tinnitus
Regulation
21 CFR 874.3400
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
78
Ingested recalls
0

Clearances, product code KLW

By decision year
78 clearances under product code KLW with a decision year between 1977 and 2026, 1980 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code KLW by decision year
YearClearances
19771
19783
19794
19805
19921
19931
19942
19963
19982
19993
20013
20023
20033
20042
20051
20062
20072
20082
20092
20101
20114
20121
20134
20144
20154
20163
20172
20182
20202
20233
20241
20262

Applicants with the most clearances

Product code KLW
Applicants holding the most 510(k) clearances under product code KLW
ApplicantClearances
Starkey Laboratories, Inc.10
Audifon-USA, Inc.3
GN Hearing A/S3
GN Resound A/S3
Siemens Hearing Instruments, Inc.3
Audiotrone2
Marpac, Inc.2
Soundcure, Inc.2
Tinnitus Control, Inc.2
Tinnitus Treatment Centers, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order