Cleared Traditional

K911689 - MODEL 330 SCREENING AUDIOMETER

K911689 is the FDA 510(k) clearance for MODEL 330 SCREENING AUDIOMETER by Virtual Corp.. It is a Class 2 Ear, Nose, Throat device (product code EWO) cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K911689 · Virtual Corp. · Ear, Nose, Throat device
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Oct 1991
Decision
188d
Days
Class 2
Risk

K911689 is an FDA 510(k) clearance for the MODEL 330 SCREENING AUDIOMETER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Virtual Corp. (Portland, US). The FDA issued a Cleared decision on October 21, 1991 after a review of 188 days - an extended review 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: 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 Virtual Corp. devices

Submission Details

510(k) Number K911689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1991
Decision Date October 21, 1991
Days to Decision 188 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
99d slower than avg
Panel avg: 89d · This submission: 188d
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 55
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K911689.
DANPLEX SCREENING AUDIOMETER
K923074 · Life-Tech Intl., Inc. · Sep 1992
ACOUSTIC APPRAISE CD-3
K923013 · Qualitone · Aug 1992
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