Cleared Traditional

K190382 - Intraocular Pressure Tonometer EASYTON

K190382 is an FDA 510(k) clearance for Intraocular Pressure Tonometer EASYTON, manufactured by Company Elamed. The device is a Class 2 Ophthalmic device with product code HKX cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K190382 · Company Elamed · Ophthalmic device
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Dec 2019
Decision
290d
Days
Class 2
Risk

K190382 is an FDA 510(k) clearance for the Intraocular Pressure Tonometer EASYTON. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Company Elamed (Yelatma, RU). The FDA issued a Cleared decision on December 6, 2019 after a review of 290 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 Company Elamed devices

FDA 510(k) Submission Details - K190382

510(k) Number K190382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2019
Decision Date December 06, 2019
Days to Decision 290 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
180d slower than avg
Panel avg: 110d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKX Device Classification - Class 2, Special Controls

Product Code HKX Tonometer, Ac-powered
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 - HKX Tonometer, Ac-powered

All 30
Devices cleared under the same product code (HKX) and FDA review panel - the closest regulatory comparables to K190382.
AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
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K181260 · Medimaging Integrated Solution, Inc (Miis) · Jun 2019
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K181143 · Keeler Instruments, Inc. · Feb 2019
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K180820 · Crystalvue Medical Corporation · Dec 2018
CORVIS ST
K113066 · Oculus Optikgerate GmbH · Nov 2012