Cleared Traditional

K913148 - COLLAGEN SHIELD FOR ACUTE CARE

K913148 is an FDA 510(k) clearance for COLLAGEN SHIELD FOR ACUTE CARE, manufactured by Vitaphore Corp.. The device is a Class 1 Ophthalmic device with product code MOE cleared through the Traditional 510(k) pathway after a 91-day FDA review.

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

FDA 510(k) Submission Details - K913148

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.

MOE Device Classification - Class 1, General Controls

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.