Cleared Traditional

K840836 - CAT 100

K840836 is the FDA 510(k) clearance for CAT 100 by CooperVision, Inc.. It is a Class 2 Ophthalmic device (product code HKX) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K840836 · CooperVision, Inc. · Ophthalmic device
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Jun 1984
Decision
116d
Days
Class 2
Risk

K840836 is an FDA 510(k) clearance for the CAT 100. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on June 19, 1984 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1930 - the FDA ophthalmic device framework. 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 CooperVision, Inc. devices

Submission Details

510(k) Number K840836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1984
Decision Date June 19, 1984
Days to Decision 116 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
6d slower than avg
Panel avg: 110d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HKX Tonometer, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1930
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.