Cleared Traditional

K874354 - AUDIOMETRIC IMPEDANCE TESTER

K874354 is the FDA 510(k) clearance for AUDIOMETRIC IMPEDANCE TESTER by Madsen Electronics (Canada) , Ltd.. It is a Class 2 Ear, Nose, Throat device (product code ETY) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K874354 · Madsen Electronics (Canada) , Ltd. · Ear, Nose, Throat device
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Jan 1988
Decision
96d
Days
Class 2
Risk

K874354 is an FDA 510(k) clearance for the AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Madsen Electronics (Canada) , Ltd. (Oakville, Ontario, CA). The FDA issued a Cleared decision on January 27, 1988 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1090 - 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

Submission Details

510(k) Number K874354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1987
Decision Date January 27, 1988
Days to Decision 96 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 89d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ETY Tester, Auditory Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1090
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 - ETY Tester, Auditory Impedance

All 11
Devices cleared under the same product code (ETY) and FDA review panel - the closest regulatory comparables to K874354.
AUTOMATIC TYMPANOMETER
K923073 · Life-Tech Intl., Inc. · Feb 1993
MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER
K905704 · Maico Hearing Instruments, Inc. · Apr 1991
STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT
K883293 · Storz Instrument Co. · Jun 1989
WELCH ALLYN TYMPANOMETER
K861516 · Welch Allyn, Inc. · Jun 1986
IMPEDANCE/PURE TONE AUDIOMETER MA620
K841568 · Maico Hearing Instruments, Inc. · Jul 1984
MA 610-IMPEDANCE AUDIOMETER
K831754 · Maico Hearing Instruments, Inc. · Jul 1983