Cleared Traditional

K003364 - VIVO 200 DPS VIVOSCAN (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K003364 · Vivosonic, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Jul 2001
Decision
264d
Days
Class 2
Risk

K003364 is an FDA 510(k) clearance for the VIVO 200 DPS VIVOSCAN. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Vivosonic, Inc. (Stamford, US). The FDA issued a Cleared decision on July 18, 2001 after a review of 264 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 Vivosonic, Inc. devices

Submission Details

510(k) Number K003364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2000
Decision Date July 18, 2001
Days to Decision 264 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 89d · This submission: 264d
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.