Cleared Traditional

K972221 - K 15 AUDIOMETER

K972221 is an FDA 510(k) clearance for K 15 AUDIOMETER, manufactured by American Electromedics Corp.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K972221 · American Electromedics Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
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Sep 1997
Decision
87d
Days
Class 2
Risk

K972221 is an FDA 510(k) clearance for the K 15 AUDIOMETER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by American Electromedics Corp. (Amherst, US). The FDA issued a Cleared decision on September 8, 1997 after a review of 87 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

FDA 510(k) Submission Details - K972221

510(k) Number K972221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1997
Decision Date September 08, 1997
Days to Decision 87 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 90d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWO Device Classification - Class 2, Special Controls

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.

Regulatory Peers - EWO Audiometer

All 134
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K972221.
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