Cleared Traditional

K874354 - AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020

K874354 is an FDA 510(k) clearance for AUDIOMETRIC IMPEDANCE TESTER, manufactured by Madsen Electronics (Canada) , Ltd.. The device is a Class 2 Ear, Nose, Throat device with 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

FDA 510(k) Submission Details - K874354

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 90d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETY Device Classification - Class 2, Special Controls

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 43
Devices cleared under the same product code (ETY) and FDA review panel - the closest regulatory comparables to K874354.
AE-105D DIAGNOSTIC TYMPANOMETER
K894260 · American Electromedics Corp. · Jan 1990
STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT
K883293 · Storz Instrument Co. · Jun 1989
AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER
K883728 · American Electromedics Corp. · Jan 1989
WELCH ALLYN TYMPANOMETER
K861516 · Welch Allyn, Inc. · Jun 1986
Z0174, IMPEDANCE AUDIOMETER
K845049 · Madsen Electronics (Canada) , Ltd. · May 1985
IMPEDANCE/PURE TONE AUDIOMETER MA620
K841568 · Maico Hearing Instruments, Inc. · Jul 1984