Cleared Traditional

K163343 - Icare HOME tonometer

K163343 is an FDA 510(k) clearance for Icare HOME tonometer, 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 112-day FDA review.

K163343 · Icare Finland OY · Ophthalmic device
Download Printable Device Report (PDF)
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Mar 2017
Decision
112d
Days
Class 2
Risk

K163343 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 March 21, 2017 after a review of 112 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

FDA 510(k) Submission Details - K163343

510(k) Number K163343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2016
Decision Date March 21, 2017
Days to Decision 112 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
2d slower than avg
Panel avg: 110d · This submission: 112d
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 Consultant

DuVal & Associates, P.A.
Mark DuVal

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HKY Tonometer, Manual

All 43
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K163343.
AT 030
K180839 · Carl Zeiss Meditec, AG · Jun 2018
CATS Tonometer Prism
K173904 · Cats Tonometer, LLC · Mar 2018
Applanation tonometer AT-1
K172728 · Takagi Seiko Co., Ltd. · Oct 2017
Icare ic100
K153694 · Icare Finland OY · Apr 2016
Applanation Tonometer
K142263 · Shanghai Mediworks Precision Instruments Co. , Ltd. · Apr 2016
Falck Medical Multifunction Tonometer, FAT1
K151491 · Falck Medical, Inc. · Jan 2016