Cleared Traditional

K840836 - CAT 100

K840836 is an FDA 510(k) clearance for CAT 100, manufactured by CooperVision, Inc.. The device is a Class 2 Ophthalmic device with 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

FDA 510(k) Submission Details - K840836

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.

HKX Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HKX Tonometer, Ac-powered

All 33
Devices cleared under the same product code (HKX) and FDA review panel - the closest regulatory comparables to K840836.
SURGICAL IOP MONITOR
K863235 · Ameritek, Inc. · Sep 1986
DIGILAB MODULAR ONE-APPLANATION TONOMETER
K863217 · Bio-Rad · Sep 1986
WOODLYN APPLANATION TONOMETER
K841762 · Woodlyn, Inc. · Aug 1984
CLERZ LUBRICATING/REWETTING SOLUTION
K833494 · CooperVision, Inc. · Jan 1984
AO NON-CONTACT II TONOMETER
K802419 · American Optical Corp. · Nov 1980
SPAN-AID BRIDGING PILLOW SYSTEM
K801518 · Span-America Medical Systems, Inc. · Aug 1980