Cleared Traditional

K922572 - 321Q MINIMUM ENERGY TINNITUS SUPPRESSOR

K922572 is an FDA 510(k) clearance for 321Q MINIMUM ENERGY TINNITUS SUPPRESSOR, manufactured by Microbio-Medics, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K922572 · Microbio-Medics, Inc. · Ear, Nose, Throat device
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Nov 1992
Decision
154d
Days
Class 2
Risk

K922572 is an FDA 510(k) clearance for the 321Q MINIMUM ENERGY TINNITUS SUPPRESSOR. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Microbio-Medics, Inc. (Memphis, US). The FDA issued a Cleared decision on November 2, 1992 after a review of 154 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 Microbio-Medics, Inc. devices

FDA 510(k) Submission Details - K922572

510(k) Number K922572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1992
Decision Date November 02, 1992
Days to Decision 154 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 89d · This submission: 154d
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 K922572.
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