Cleared Traditional

K031713 - AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS

K031713 is an FDA 510(k) clearance for AUDIOMETER, manufactured by Viasys Healthcare, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K031713 · Viasys Healthcare, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
71d
Days
Class 2
Risk

K031713 is an FDA 510(k) clearance for the AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Viasys Healthcare, Inc. (Stoughton, US). The FDA issued a Cleared decision on August 12, 2003 after a review of 71 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 Viasys Healthcare, Inc. devices

FDA 510(k) Submission Details - K031713

510(k) Number K031713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2003
Decision Date August 12, 2003
Days to Decision 71 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
19d faster than avg
Panel avg: 90d · This submission: 71d
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 144
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K031713.
HEARID WIDEBAND MIDDLE EAR POWER ANALYZER
K053216 · Mimosa Acoustics, Inc. · Feb 2006
ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.
K052562 · Interacoustics AS · Dec 2005
AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS
K043219 · Interacoustics AS · Feb 2005
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