Cleared Traditional

PERMALID PAK (K842781) - FDA 510(k) Clearance

K842781 · CooperVision, Inc. · Ophthalmic device
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Aug 1985
Decision
381d
Days
-
Risk

K842781 is an FDA 510(k) clearance for the PERMALID PAK.

Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on August 1, 1985 after a review of 381 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 CooperVision, Inc. devices

Submission Details

510(k) Number K842781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received July 16, 1984
Decision Date August 01, 1985
Days to Decision 381 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
271d slower than avg
Panel avg: 110d · This submission: 381d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -