Cleared Special

K200966 - Icare HOME Tonometer (FDA 510(k) Clearance)

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

K200966 · Icare Finland OY · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
27d
Days
Class 2
Risk

K200966 is an FDA 510(k) clearance for the Icare HOME Tonometer. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Icare Finland OY (Vantaa, FI). The FDA issued a Cleared decision on May 7, 2020 after a review of 27 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 Icare Finland OY devices

Submission Details

510(k) Number K200966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2020
Decision Date May 07, 2020
Days to Decision 27 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 110d · This submission: 27d
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 Peers - HKY Tonometer, Manual

All 55
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K200966.
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
CATS-L Tonometer™ Prism
K234037 · Cats Tonometer, LLC · Feb 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