Cleared Traditional

K844249 - K-SOL

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

FDA 510(k) Submission Details - K844249

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.

LYX Device Classification - Class 0,

Product Code LYX Media, Corneal Storage
Device Class -