Cleared Traditional

K910247 - ZODIAC 901 MIDDLE-EAR ANALYZER

K910247 is an FDA 510(k) clearance for ZODIAC 901 MIDDLE-EAR ANALYZER, 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 148-day FDA review.

K910247 · Madsen Electronics (Canada) , Ltd. · Ear, Nose, Throat device
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Jun 1991
Decision
148d
Days
Class 2
Risk

K910247 is an FDA 510(k) clearance for the ZODIAC 901 MIDDLE-EAR ANALYZER. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Madsen Electronics (Canada) , Ltd. (North Tonawanda, US). The FDA issued a Cleared decision on June 19, 1991 after a review of 148 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 - K910247

510(k) Number K910247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1991
Decision Date June 19, 1991
Days to Decision 148 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
58d slower than avg
Panel avg: 90d · This submission: 148d
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 K910247.
AUTOMATIC TYMPANOMETER
K923073 · Life-Tech Intl., Inc. · Feb 1993
AE-206 TYMPNOMWRWE(R) AUDIOMETER
K924933 · American Electromedics Corp. · Jan 1993
AUTOMATIC IMPEDANCE METER AE-205
K924934 · American Electromedics Corp. · Jan 1993
MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER
K905704 · Maico Hearing Instruments, Inc. · Apr 1991
MIDDLE EAR ANALYZER, MODEL AE-803
K905213 · American Electromedics Corp. · Feb 1991
IMMITTANCE METER, MODEL AE-105D/S
K905212 · American Electromedics Corp. · Feb 1991