Cleared Traditional

KS 5 - CLINICAL AUDIOMETER (K931322) - FDA 510(k) Clearance

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

K931322 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat device
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Aug 1994
Decision
521d
Days
Class 2
Risk

K931322 is an FDA 510(k) clearance for the KS 5 - CLINICAL AUDIOMETER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Maico Hearing Instruments, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 19, 1994 after a review of 521 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1050 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Maico Hearing Instruments, Inc. devices

Submission Details

510(k) Number K931322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1993
Decision Date August 19, 1994
Days to Decision 521 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
432d slower than avg
Panel avg: 89d · This submission: 521d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EWO Audiometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1050
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.