Cleared Traditional

Keeler TonoCare Tonometer (K181143) - FDA 510(k) Clearance

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

K181143 · Keeler Instruments, Inc. · Ophthalmic device
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Feb 2019
Decision
283d
Days
Class 2
Risk

K181143 is an FDA 510(k) clearance for the Keeler TonoCare Tonometer. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Keeler Instruments, Inc. (Malvern, US). The FDA issued a Cleared decision on February 8, 2019 after a review of 283 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 Keeler Instruments, Inc. devices

Submission Details

510(k) Number K181143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2018
Decision Date February 08, 2019
Days to Decision 283 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
173d slower than avg
Panel avg: 110d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 57
Devices cleared under the same product code (HKX) and FDA review panel - the closest regulatory comparables to K181143.
AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
K253039 · Topcon Corporation · Nov 2025
VS Tabletop Tonometer
K223739 · Medimaging Integrated Solution, Inc. · Nov 2023
Intraocular Pressure Tonometer EASYTON
K190382 · Company Elamed · Dec 2019
MiiS Horus Scope DPT 100
K181260 · Medimaging Integrated Solution, Inc (Miis) · Jun 2019
Tono Vue Non-Contact Tonometer
K180820 · Crystalvue Medical Corporation · Dec 2018