Cleared Traditional

K791467 - TA-10 PORTABLE SCREENING AUDIOMETER

K791467 is the FDA 510(k) clearance for TA-10 PORTABLE SCREENING AUDIOMETER by Teledyne Avionics Div. of Teledyne. It is a Class 2 Ear, Nose, Throat device (product code EWO) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K791467 · Teledyne Avionics Div. of Teledyne · Ear, Nose, Throat device
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Sep 1979
Decision
53d
Days
Class 2
Risk

K791467 is an FDA 510(k) clearance for the TA-10 PORTABLE SCREENING AUDIOMETER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Teledyne Avionics Div. of Teledyne (Mchenry, US). The FDA issued a Cleared decision on September 28, 1979 after a review of 53 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 Teledyne Avionics Div. of Teledyne devices

Submission Details

510(k) Number K791467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1979
Decision Date September 28, 1979
Days to Decision 53 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
36d faster than avg
Panel avg: 89d · This submission: 53d
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.