Cleared Traditional

K874224 - BIO-COR II COLLAGEN CORNEAL SHIELD

K874224 is an FDA 510(k) clearance for BIO-COR II COLLAGEN CORNEAL SHIELD, manufactured by Bausch & Lomb, Inc.. The device is a Class 1 Ophthalmic device with product code MOE cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K874224 · Bausch & Lomb, Inc. · Ophthalmic device
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Jan 1988
Decision
98d
Days
Class 1
Risk

K874224 is an FDA 510(k) clearance for the BIO-COR II COLLAGEN CORNEAL SHIELD. Classified as Collagen Corneal Shield (product code MOE), Class I - General Controls.

Submitted by Bausch & Lomb, Inc. (Clearwater, US). The FDA issued a Cleared decision on January 22, 1988 after a review of 98 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.

FDA 510(k) Submission Details - K874224

510(k) Number K874224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1987
Decision Date January 22, 1988
Days to Decision 98 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 110d · This submission: 98d
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.

Regulatory Peers - MOE Collagen Corneal Shield

All 18
Devices cleared under the same product code (MOE) and FDA review panel - the closest regulatory comparables to K874224.
LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL
K884363 · Bausch & Lomb Pharmaceutical, Inc. · Nov 1988
LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL
K884364 · Bausch & Lomb Pharmaceutical, Inc. · Nov 1988
COLLAGEN SHIELD
K882762 · Chiron Ophthalmics · Sep 1988
BIO-COR EXT COLLAGEN CORNEAL SHIELD
K874225 · Bausch & Lomb, Inc. · Jan 1988
FYODOROV COLLAGEN CORNEAL SHIELD
K862315 · Medical Technology Development Corp. · Jan 1987
K874224 · BIO-COR II COLLAGEN CORNEAL SHIELD
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