Cleared Traditional

THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER (K913356) - FDA 510(k) Clearance

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

K913356 · Monitor Instruments, Inc. · Ear, Nose, Throat device
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Dec 1991
Decision
128d
Days
Class 2
Risk

K913356 is an FDA 510(k) clearance for the THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Monitor Instruments, Inc. (Chapel Hill, US). The FDA issued a Cleared decision on December 5, 1991 after a review of 128 days - within the typical 510(k) review window.

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: 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 Monitor Instruments, Inc. devices

Submission Details

510(k) Number K913356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1991
Decision Date December 05, 1991
Days to Decision 128 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
39d slower than avg
Panel avg: 89d · This submission: 128d
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.