Cleared Traditional

K003364 - VIVO 200 DPS VIVOSCAN

K003364 is an FDA 510(k) clearance for VIVO 200 DPS VIVOSCAN, manufactured by Vivosonic, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K003364 · Vivosonic, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K003364

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 90d · This submission: 264d
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 143
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K003364.
BIO-LOGIC INSERT EARPHONES
K031352 · Bio-Logic Systems Corp. · Jul 2003
BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
K021801 · Bio-Logic Systems Corp. · Jun 2002
GSI AUDERA
K011135 · Nicolet Biomedical · Jul 2001
ETYMOTIC RESEARCH ER-10D OAE PROBE
K011114 · Etymotic Research · Jul 2001
ICS MEDICAL CHARTR OAE WITH TYMP
K011181 · Ics Medical Corp. · Jun 2001
HINT AUDIOMETER, OR HINT
K003913 · Maico-Diagnostics · Mar 2001