Cleared Traditional

K220852 - iCare IC200

K220852 is an FDA 510(k) clearance for iCare IC200, manufactured by Icare Finland OY. The device is a Class 2 Ophthalmic device with product code HKY cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K220852 · Icare Finland OY · Ophthalmic device
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Oct 2022
Decision
197d
Days
Class 2
Risk

K220852 is an FDA 510(k) clearance for the iCare IC200. 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 October 6, 2022 after a review of 197 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 Icare Finland OY devices

FDA 510(k) Submission Details - K220852

510(k) Number K220852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2022
Decision Date October 06, 2022
Days to Decision 197 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
87d slower than avg
Panel avg: 110d · This submission: 197d
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 K220852.
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 HOME2
K211355 · Icare Finland OY · Jan 2022
CATS®-D Tonometer Prism
K203850 · Cats Tonometer, LLC · Jun 2021
Icare HOME Tonometer
K200966 · Icare Finland OY · May 2020