Cleared Traditional

K942716 - AUDIO EXPERT AUDIOMETER

K942716 is the FDA 510(k) clearance for AUDIO EXPERT AUDIOMETER by Beltone Electronics Corp.. It is a Class 2 Ear, Nose, Throat device (product code EWO) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K942716 · Beltone Electronics Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
85d
Days
Class 2
Risk

K942716 is an FDA 510(k) clearance for the AUDIO EXPERT AUDIOMETER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Beltone Electronics Corp. (Chicago, US). The FDA issued a Cleared decision on September 2, 1994 after a review of 85 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 Beltone Electronics Corp. devices

Submission Details

510(k) Number K942716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1994
Decision Date September 02, 1994
Days to Decision 85 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 89d · This submission: 85d
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.

Regulatory Peers - EWO Audiometer

All 54
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K942716.
PROPHET
K953884 · Qualitone · Oct 1995
BELTONE PERSONAL HEARING SCREENER
K943616 · Beltone Electronics Corp. · Jul 1995
BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST
K944735 · Bio-Logic Systems Corp. · Dec 1994
KS 5 - CLINICAL AUDIOMETER
K931322 · Maico Hearing Instruments, Inc. · Aug 1994
BELTONE SERIES 100 AUDIOMETERS
K940216 · Beltone Electronics Corp. · Jul 1994
ODYSSEY CLINICAL AUDIOMETER
K935348 · Qualitone · Feb 1994