Cleared Traditional

K881760 - AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER (FDA 510(k) Clearance)

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

K881760 · American Electromedics Corp. · Ear, Nose, Throat device
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Jun 1988
Decision
46d
Days
Class 2
Risk

K881760 is an FDA 510(k) clearance for the AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by American Electromedics Corp. (Hudson, US). The FDA issued a Cleared decision on June 10, 1988 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1050 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Electromedics Corp. devices

Submission Details

510(k) Number K881760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1988
Decision Date June 10, 1988
Days to Decision 46 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
43d faster than avg
Panel avg: 89d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EWO Audiometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1050
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.