Cleared Traditional

321Q MINIMUM ENERGY TINNITUS SUPPRESSOR (K922572) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 75
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K922572.
Peace N Quiet (0.7.0)
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K221168 · Goldenear Company, Inc. · Feb 2023
SilentCloud
K221125 · Aureliym GmbH · Jan 2023
Multiflex Tinnitus Technology
K201370 · Starkey Laboratories, Inc. · Jun 2020
Tinnitus Sound Generator Module
K193303 · GN Hearing A/S · Feb 2020