Cleared Traditional

EYE ARTIFICIAL CUSTOM (K904962) - FDA 510(k) Clearance

Class I Ophthalmic device.

K904962 · Midwest Eye Laboratories, Inc. · Ophthalmic device
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Aug 1991
Decision
298d
Days
Class 1
Risk

K904962 is an FDA 510(k) clearance for the EYE ARTIFICIAL CUSTOM. Classified as Eye, Artificial, Non-custom (product code HQH), Class I - General Controls.

Submitted by Midwest Eye Laboratories, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 30, 1991 after a review of 298 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3200 - the FDA ophthalmic 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 Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Midwest Eye Laboratories, Inc. devices

Submission Details

510(k) Number K904962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1990
Decision Date August 30, 1991
Days to Decision 298 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
188d slower than avg
Panel avg: 110d · This submission: 298d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HQH Eye, Artificial, Non-custom
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.3200
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.