Cleared Traditional

K945032 - VOYAGER 522

K945032 is an FDA 510(k) clearance for VOYAGER 522, manufactured by Madsen Electronics, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K945032 · Madsen Electronics, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
112d
Days
Class 2
Risk

K945032 is an FDA 510(k) clearance for the VOYAGER 522. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Madsen Electronics, Inc. (Minnetonka, US). The FDA issued a Cleared decision on February 2, 1995 after a review of 112 days - within the typical 510(k) review window.

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 Madsen Electronics, Inc. devices

FDA 510(k) Submission Details - K945032

510(k) Number K945032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1994
Decision Date February 02, 1995
Days to Decision 112 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
23d slower than avg
Panel avg: 89d · This submission: 112d
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 55
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K945032.
SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT
K961447 · Bio-Logic Systems Corp. · May 1996
PROPHET
K953884 · Qualitone · Oct 1995
BELTONE PERSONAL HEARING SCREENER
K943616 · Beltone Electronics Corp. · Jul 1995
BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST
K944735 · Bio-Logic Systems Corp. · Dec 1994
AUDIO EXPERT AUDIOMETER
K942716 · Beltone Electronics Corp. · Sep 1994
KS 5 - CLINICAL AUDIOMETER
K931322 · Maico Hearing Instruments, Inc. · Aug 1994