Cleared Traditional

K863984 - MODEL 320 TWO CHANNEL AUDIOMETER

K863984 is an FDA 510(k) clearance for MODEL 320 TWO CHANNEL AUDIOMETER, manufactured by Virtual Corp.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K863984 · Virtual Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1986
Decision
35d
Days
Class 2
Risk

K863984 is an FDA 510(k) clearance for the MODEL 320 TWO CHANNEL AUDIOMETER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Virtual Corp. (Portland, US). The FDA issued a Cleared decision on November 18, 1986 after a review of 35 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 Virtual Corp. devices

FDA 510(k) Submission Details - K863984

510(k) Number K863984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1986
Decision Date November 18, 1986
Days to Decision 35 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
55d faster than avg
Panel avg: 90d · This submission: 35d
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 130
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K863984.
DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602
K883478 · Madsen Electronics (Canada) , Ltd. · Nov 1988
AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER
K881760 · American Electromedics Corp. · Jun 1988
THE BELTONE 2000 AUDIOMETER
K875360 · Beltone Electronics Corp. · Feb 1988
PHOENIX SYSTEM SEVEN.
K862592 · Nicolet Biomedical Instruments · Sep 1986
AUDIOMETER/MASTER HEARING AID MF6
K862770 · Maico Hearing Instruments, Inc. · Aug 1986
DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER
K854835 · Miracle-Ear/Dahlberg, Inc. · Mar 1986