Cleared Traditional

K924991 - MICRO MASKER

K924991 is an FDA 510(k) clearance for MICRO MASKER, manufactured by Associated Hearing Instruments. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K924991 · Associated Hearing Instruments · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
256d
Days
Class 2
Risk

K924991 is an FDA 510(k) clearance for the MICRO MASKER. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Associated Hearing Instruments (Upper Darby, US). The FDA issued a Cleared decision on June 14, 1993 after a review of 256 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3400 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Associated Hearing Instruments devices

FDA 510(k) Submission Details - K924991

510(k) Number K924991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1992
Decision Date June 14, 1993
Days to Decision 256 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
167d slower than avg
Panel avg: 89d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLW Device Classification - Class 2, Special Controls

Product Code KLW Masker, Tinnitus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - KLW Masker, Tinnitus

All 22
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K924991.
STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER
K964216 · Starkey Laboratories, Inc. · Dec 1996
STARKEY TM AIR CONDUCTION TINNITUS MASKER
K963838 · Starkey Laboratories, Inc. · Nov 1996
STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER
K963995 · Starkey Laboratories, Inc. · Nov 1996
MINUET MASKER
K800784 · Beltone Electronics Corp. · Apr 1980
MODEL TM5 BEHIND EAR TINNITUS MASKER
K791790 · Starkey Laboratories, Inc. · Oct 1979
HEARING AID, MODEL MA-1
K791142 · Starkey Laboratories, Inc. · Sep 1979