Cleared Traditional

K885015 - COI 72 HR COLLAGEN SHIELD

K885015 is an FDA 510(k) clearance for COI 72 HR COLLAGEN SHIELD, manufactured by Chiron Ophthalmics. The device is a Class 1 Ophthalmic device with product code MOE cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K885015 · Chiron Ophthalmics · Ophthalmic device
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Jun 1989
Decision
200d
Days
Class 1
Risk

K885015 is an FDA 510(k) clearance for the COI 72 HR COLLAGEN SHIELD. Classified as Collagen Corneal Shield (product code MOE), Class I - General Controls.

Submitted by Chiron Ophthalmics (Irvine, US). The FDA issued a Cleared decision on June 23, 1989 after a review of 200 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 Chiron Ophthalmics devices

FDA 510(k) Submission Details - K885015

510(k) Number K885015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1988
Decision Date June 23, 1989
Days to Decision 200 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 110d · This submission: 200d
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.