Cleared Traditional

DIGITAL AUDIOMETER/HEARING AID 3100 (K833883) - FDA 510(k) Clearance

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

K833883 · Frye Electronics, Inc. · Ear, Nose, Throat device
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Feb 1984
Decision
104d
Days
Class 2
Risk

K833883 is an FDA 510(k) clearance for the DIGITAL AUDIOMETER/HEARING AID 3100. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Frye Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984 after a review of 104 days - within the typical 510(k) review window.

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: 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 Frye Electronics, Inc. devices

Submission Details

510(k) Number K833883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1983
Decision Date February 21, 1984
Days to Decision 104 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
15d slower than avg
Panel avg: 89d · This submission: 104d
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.

Regulatory Peers - EWO Audiometer

All 234
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K833883.
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