Cleared Traditional

K854534 - DIGITAL SCREENING AUDIOMETER DSA6214

K854534 is an FDA 510(k) clearance for DIGITAL SCREENING AUDIOMETER DSA6214, manufactured by Madsen Electronics (Canada) , Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K854534 · Madsen Electronics (Canada) , Ltd. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1986
Decision
92d
Days
Class 2
Risk

K854534 is an FDA 510(k) clearance for the DIGITAL SCREENING AUDIOMETER DSA6214. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Madsen Electronics (Canada) , Ltd. (Oakville, Ontario, CA). The FDA issued a Cleared decision on February 13, 1986 after a review of 92 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 (Canada) , Ltd. devices

FDA 510(k) Submission Details - K854534

510(k) Number K854534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1985
Decision Date February 13, 1986
Days to Decision 92 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 90d · This submission: 92d
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 130
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K854534.
PHOENIX SYSTEM SEVEN.
K862592 · Nicolet Biomedical Instruments · Sep 1986
AUDIOMETER/MASTER HEARING AID MF6
K862770 · Maico Hearing Instruments, Inc. · Aug 1986
DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER
K854835 · Miracle-Ear/Dahlberg, Inc. · Mar 1986
MA25 PORTABLE AUDIOMETER
K853919 · Maico Hearing Instruments, Inc. · Dec 1985
UP800 A UNIVERSAL PRINTER
K845050 · Madsen Electronics (Canada) , Ltd. · May 1985
AUDIOMETER MA728
K841567 · Maico Hearing Instruments, Inc. · Jun 1984