Cleared Traditional

BENZETHONIUM CHLORIDE (K833903) - FDA 510(k) Clearance

K833903 · Blairex Laboratories, Inc. · Ophthalmic device
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May 1984
Decision
198d
Days
-
Risk

K833903 is an FDA 510(k) clearance for the BENZETHONIUM CHLORIDE. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Blairex Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on May 30, 1984 after a review of 198 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 Blairex Laboratories, Inc. devices

Submission Details

510(k) Number K833903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1983
Decision Date May 30, 1984
Days to Decision 198 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 110d · This submission: 198d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPX Lens, Contact (polymethylmethacrylate)
Device Class -