Cleared Traditional

K905213 - MIDDLE EAR ANALYZER

K905213 is an FDA 510(k) clearance for MIDDLE EAR ANALYZER, manufactured by American Electromedics Corp.. The device is a Class 2 Ear, Nose, Throat device with product code ETY cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K905213 · American Electromedics Corp. · Ear, Nose, Throat device
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Feb 1991
Decision
92d
Days
Class 2
Risk

K905213 is an FDA 510(k) clearance for the MIDDLE EAR ANALYZER, MODEL AE-803. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by American Electromedics Corp. (Hudson, US). The FDA issued a Cleared decision on February 20, 1991 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 874.1090 - 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 American Electromedics Corp. devices

FDA 510(k) Submission Details - K905213

510(k) Number K905213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1990
Decision Date February 20, 1991
Days to Decision 92 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
3d slower than avg
Panel avg: 89d · This submission: 92d
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 11
Devices cleared under the same product code (ETY) and FDA review panel - the closest regulatory comparables to K905213.
HANDTYMP
K923072 · Life-Tech Intl., Inc. · Mar 1993
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