Cleared Traditional

K842814 - PERMALID LINER PAK

K842814 · CooperVision, Inc. · Ophthalmic device
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Aug 1985
Decision
379d
Days
-
Risk

K842814 is an FDA 510(k) clearance for the PERMALID LINER PAK.

Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on August 1, 1985 after a review of 379 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

FDA 510(k) Submission Details - K842814

510(k) Number K842814 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 18, 1984
Decision Date August 01, 1985
Days to Decision 379 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
269d slower than avg
Panel avg: 110d · This submission: 379d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -