Cleared Traditional

OXY-PMMA (K821866) - FDA 510(k) Clearance

K821866 · Petrarch Systems & Professional Pharm · Ophthalmic device
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Sep 1982
Decision
82d
Days
-
Risk

K821866 is an FDA 510(k) clearance for the OXY-PMMA. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Petrarch Systems & Professional Pharm (Mchenry, US). The FDA issued a Cleared decision on September 14, 1982 after a review of 82 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 K821866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1982
Decision Date September 14, 1982
Days to Decision 82 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 110d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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