Cleared Special

K234037 - CATS-L Tonometer™ Prism (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K234037 · Cats Tonometer, LLC · Ophthalmic device
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Feb 2024
Decision
50d
Days
Class 2
Risk

K234037 is an FDA 510(k) clearance for the CATS-L Tonometer™ Prism. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Cats Tonometer, LLC (Tucson, US). The FDA issued a Cleared decision on February 9, 2024 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1930 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cats Tonometer, LLC devices

Submission Details

510(k) Number K234037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2023
Decision Date February 09, 2024
Days to Decision 50 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 110d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HKY Tonometer, Manual
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 Consultant

K.Hodai Consulting, Inc.
Omid Khodai, OD, MS, RAC

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HKY Tonometer, Manual

All 55
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K234037.
iCare ST500 (TA04)
K241447 · Icare Finland OY · Sep 2024
Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)
K233516 · Reichert, Inc. · May 2024
Applanation Tonometer HT-5000
K232143 · Huvitz Co., Ltd. · Oct 2023
iCare IC200
K220852 · Icare Finland OY · Oct 2022
iCare HOME2
K211355 · Icare Finland OY · Jan 2022
CATS®-D Tonometer Prism
K203850 · Cats Tonometer, LLC · Jun 2021