Cleared Traditional

K203850 - CATS-D Tonometer Prism

K203850 is an FDA 510(k) clearance for CATS-D Tonometer Prism, manufactured by Cats Tonometer, LLC. The device is a Class 2 Ophthalmic device with product code HKY cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K203850 · Cats Tonometer, LLC · Ophthalmic device
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Jun 2021
Decision
165d
Days
Class 2
Risk

K203850 is an FDA 510(k) clearance for the CATS®-D 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 June 14, 2021 after a review of 165 days - an extended review cycle.

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 Cats Tonometer, LLC devices

FDA 510(k) Submission Details - K203850

510(k) Number K203850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2020
Decision Date June 14, 2021
Days to Decision 165 days
Submission Type Traditional
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
55d slower than avg
Panel avg: 110d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKY Device Classification - Class 2, Special Controls

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 Peers - HKY Tonometer, Manual

All 17
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K203850.
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
Icare HOME Tonometer
K200966 · Icare Finland OY · May 2020
Icare ic200
K190316 · Icare Finland OY · Jan 2020
Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q
K191314 · Chongqing Sunkingdom Medical Instrument Co., Ltd. · Dec 2019