Cleared Traditional

K241447 - iCare ST500 (TA04) (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence.

K241447 · Icare Finland OY · Ophthalmic device
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Sep 2024
Decision
128d
Days
Class 2
Risk

K241447 is an FDA 510(k) clearance for the iCare ST500 (TA04). 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 September 27, 2024 after a review of 128 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K241447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2024
Decision Date September 27, 2024
Days to Decision 128 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
18d slower than avg
Panel avg: 110d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05742009 Completed Interventional Industry-sponsored

iCare ST500 Clinical Trial

Clinical Validation of a Slit Lamp Mounted Rebound Tonometer

165
Patients (actual)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Intraocular Pressure
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Icare Finland Oy (industry)
Started 2023-06-05 → Primary completion 2023-11-14
Primary outcome
Demonstrate compliance with ANSI Z80.10:2014-Ophthalmics-Ophthalmic Instruments-Tonometers
Study completed - no results published. This trial concluded in 2023 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - HKY Tonometer, Manual

All 55
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K241447.
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
CATS®-D Tonometer Prism
K203850 · Cats Tonometer, LLC · Jun 2021