Cleared Traditional

K831431 - AUDIOMETER MODEL-500

K831431 is an FDA 510(k) clearance for AUDIOMETER MODEL-500, manufactured by Audimax. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K831431 · Audimax · Ear, Nose, Throat device
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Jun 1983
Decision
57d
Days
Class 2
Risk

K831431 is an FDA 510(k) clearance for the AUDIOMETER MODEL-500. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Audimax (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 57 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Audimax devices

FDA 510(k) Submission Details - K831431

510(k) Number K831431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1983
Decision Date June 30, 1983
Days to Decision 57 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 89d · This submission: 57d
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 K831431.
AUDIOMETER/MASTER HEARING AID MF6
K862770 · Maico Hearing Instruments, Inc. · Aug 1986
MA25 PORTABLE AUDIOMETER
K853919 · Maico Hearing Instruments, Inc. · Dec 1985
AUDIOMETER MA728
K841567 · Maico Hearing Instruments, Inc. · Jun 1984
PORTABLE AUDIOMETERS
K811727 · Maico Hearing Instruments, Inc. · Jul 1981
TINNITUS RESEARCH AUDIOMETER
K802560 · Starkey Laboratories, Inc. · Nov 1980
RION DIAGNOSTIC AUDIOMETER
K802207 · Rion Acoustic Instruments, Inc. · Sep 1980