Cleared Traditional

EYEOPENER (K904469) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K904469 · Kc Medical Industries · Ear, Nose, Throat device
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Jun 1991
Decision
270d
Days
Class 1
Risk

K904469 is an FDA 510(k) clearance for the EYEOPENER. Classified as Gauge, Measuring (product code JYJ), Class I - General Controls.

Submitted by Kc Medical Industries (Oshkosh, US). The FDA issued a Cleared decision on June 28, 1991 after a review of 270 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - 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.

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Submission Details

510(k) Number K904469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1990
Decision Date June 28, 1991
Days to Decision 270 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
181d slower than avg
Panel avg: 89d · This submission: 270d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JYJ Gauge, Measuring
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.