Cleared Traditional

FYODOROV COLLAGEN CORNEAL SHIELD (K862315) - FDA 510(k) Clearance

Class I Ophthalmic device.

K862315 · Medical Technology Development Corp. · Ophthalmic device
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Jan 1987
Decision
203d
Days
Class 1
Risk

K862315 is an FDA 510(k) clearance for the FYODOROV COLLAGEN CORNEAL SHIELD. Classified as Collagen Corneal Shield (product code MOE), Class I - General Controls.

Submitted by Medical Technology Development Corp. (Clearwater, US). The FDA issued a Cleared decision on January 7, 1987 after a review of 203 days - an extended review cycle.

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 Medical Technology Development Corp. devices

Submission Details

510(k) Number K862315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1986
Decision Date January 07, 1987
Days to Decision 203 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 110d · This submission: 203d
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.