Cleared Traditional

3M CORNEAL SYSTEM (CORNEAL PRESERVATION MEDIUM) (K863129) - FDA 510(k) Clearance

K863129 · 3M Company · Ophthalmic device
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Sep 1986
Decision
33d
Days
-
Risk

K863129 is an FDA 510(k) clearance for the 3M CORNEAL SYSTEM (CORNEAL PRESERVATION MEDIUM). Classified as Media, Corneal Storage (product code LYX).

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on September 17, 1986 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K863129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1986
Decision Date September 17, 1986
Days to Decision 33 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
77d faster than avg
Panel avg: 110d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYX Media, Corneal Storage
Device Class -