Cleared Traditional

K190316 - Icare ic200 (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 K190316.
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