Cleared Traditional

DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER (K943215) - FDA 510(k) Clearance

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

K943215 · Kenneth Ullrich · Ear, Nose, Throat device
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May 1995
Decision
311d
Days
Class 2
Risk

K943215 is an FDA 510(k) clearance for the DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Kenneth Ullrich (Wenatchee, US). The FDA issued a Cleared decision on May 12, 1995 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

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Submission Details

510(k) Number K943215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1994
Decision Date May 12, 1995
Days to Decision 311 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 89d · This submission: 311d
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.