Cleared Traditional

K844249 - K-SOL (FDA 510(k) Clearance)

K844249 · Cilco, Inc. · Ophthalmic device
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Apr 1985
Decision
179d
Days
-
Risk

K844249 is an FDA 510(k) clearance for the K-SOL. Classified as Media, Corneal Storage (product code LYX).

Submitted by Cilco, Inc. (Huntington, US). The FDA issued a Cleared decision on April 30, 1985 after a review of 179 days - an extended review 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: 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 Cilco, Inc. devices

Submission Details

510(k) Number K844249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1984
Decision Date April 30, 1985
Days to Decision 179 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 110d · This submission: 179d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYX Media, Corneal Storage
Device Class -