510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K924991Substantially Equivalent

Micro Masker

Associated Hearing Instruments, Upper Darby PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924991 is the FDA 510(k) clearance record for MICRO MASKER, a class II device, cleared for Associated Hearing Instruments on under FDA product code KLW (Masker, Tinnitus). FDA records list one 510(k) clearance for Associated Hearing Instruments. As of , FDA records show no recalls naming K924991.

Clearance record

Decision date
Received
(256 days to decision)
Product code
KLW Masker, Tinnitus
Regulation
21 CFR 874.3400
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Associated Hearing Instruments 6796 Market St., Upper Darby PA
510(k) summary
Summary
Third party review
No

Clearances, product code KLW

Trailing 12 months
2 clearances under product code KLW in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KLW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260