Cleared Traditional

K913356 - THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER

K913356 is an FDA 510(k) clearance for THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER, manufactured by Monitor Instruments, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 128-day FDA review.

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

FDA 510(k) Submission Details - K913356

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.

EWO Device Classification - Class 2, Special Controls

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.

Regulatory Peers - EWO Audiometer

All 55
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K913356.
DANPLEX SCREENING AUDIOMETER
K923074 · Life-Tech Intl., Inc. · Sep 1992
ACOUSTIC APPRAISE CD-3
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THE BELTONE AUDIO SCOUT
K915323 · Beltone Electronics Corp. · May 1992
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM
K912669 · Resound Corp. · Sep 1991
MAICO MA800 AUDIOMETER
K911368 · Maico Hearing Instruments, Inc. · Jun 1991
ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID
K904544 · Qualitone · Oct 1990