Cleared Traditional

THE CHEN MEDIUM (K954548) - FDA 510(k) Clearance

K954548 · Chen Ophthalmic Laboratories · Ophthalmic device
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May 1996
Decision
231d
Days
-
Risk

K954548 is an FDA 510(k) clearance for the THE CHEN MEDIUM. Classified as Media, Corneal Storage (product code LYX).

Submitted by Chen Ophthalmic Laboratories (Phoenix, US). The FDA issued a Cleared decision on May 20, 1996 after a review of 231 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.

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Submission Details

510(k) Number K954548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1995
Decision Date May 20, 1996
Days to Decision 231 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 110d · This submission: 231d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYX Media, Corneal Storage
Device Class -