Cleared Traditional

K913148 - COLLAGEN SHIELD FOR ACUTE CARE (FDA 510(k) Clearance)

Class I Ophthalmic device.

K913148 · Vitaphore Corp. · Ophthalmic device
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Oct 1991
Decision
91d
Days
Class 1
Risk

K913148 is an FDA 510(k) clearance for the COLLAGEN SHIELD FOR ACUTE CARE. Classified as Collagen Corneal Shield (product code MOE), Class I - General Controls.

Submitted by Vitaphore Corp. (Menlo Park, US). The FDA issued a Cleared decision on October 15, 1991 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4750 - 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 Vitaphore Corp. devices

Submission Details

510(k) Number K913148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1991
Decision Date October 15, 1991
Days to Decision 91 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 110d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MOE Collagen Corneal Shield
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4750
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.