Cleared Traditional

K874516 - MODEL V4 AUDIOMETER

K874516 is an FDA 510(k) clearance for MODEL V4 AUDIOMETER, manufactured by Digital Hearing Systems Corp.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K874516 · Digital Hearing Systems Corp. · Ear, Nose, Throat device
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Dec 1987
Decision
42d
Days
Class 2
Risk

K874516 is an FDA 510(k) clearance for the MODEL V4 AUDIOMETER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Digital Hearing Systems Corp. (Ann Arbor, US). The FDA issued a Cleared decision on December 14, 1987 after a review of 42 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 Digital Hearing Systems Corp. devices

FDA 510(k) Submission Details - K874516

510(k) Number K874516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1987
Decision Date December 14, 1987
Days to Decision 42 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
47d faster than avg
Panel avg: 89d · This submission: 42d
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 K874516.
AUDIOSCOPE 3 MODEL 23300 ACCESSORIES
K884218 · Welch Allyn, Inc. · Mar 1989
AUDIOMETER DIGITAL HEARING SYSTEM
K884044 · Resound Corp. · Feb 1989
THE BELTONE 2000 AUDIOMETER
K875360 · Beltone Electronics Corp. · Feb 1988
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