Cleared Traditional

K190316 - Icare ic200

K190316 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 335-day FDA review.

K190316 · Icare Finland OY · Ophthalmic device
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Jan 2020
Decision
335d
Days
Class 2
Risk

K190316 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 January 14, 2020 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K190316

510(k) Number K190316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2019
Decision Date January 14, 2020
Days to Decision 335 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
225d slower than avg
Panel avg: 110d · This submission: 335d
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 K190316.
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
Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q
K191314 · Chongqing Sunkingdom Medical Instrument Co., Ltd. · Dec 2019
Applanation tonometer AT-2
K182491 · Takagi Seiko Co., Ltd. · Dec 2018
AT 030
K180839 · Carl Zeiss Meditec, AG · Jun 2018