Cleared Traditional

K924933 - AE-206 TYMPNOMWRWE(R) AUDIOMETER (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924933 · American Electromedics Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
113d
Days
Class 2
Risk

K924933 is an FDA 510(k) clearance for the AE-206 TYMPNOMWRWE(R) AUDIOMETER. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by American Electromedics Corp. (Amherst, US). The FDA issued a Cleared decision on January 21, 1993 after a review of 113 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

Submission Details

510(k) Number K924933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1992
Decision Date January 21, 1993
Days to Decision 113 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 89d · This submission: 113d
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.