Cleared Traditional

K181143 - Keeler TonoCare Tonometer

K181143 is an FDA 510(k) clearance for Keeler TonoCare Tonometer, manufactured by Keeler Instruments, Inc.. The device is a Class 2 Ophthalmic device with product code HKX cleared through the Traditional 510(k) pathway after a 283-day FDA review.

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

FDA 510(k) Submission Details - K181143

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.

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 K181143.
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
CORVIS ST
K113066 · Oculus Optikgerate GmbH · Nov 2012
FULL AUTO TONOMETER MODEL TX-20
K111710 · Canon Inc. -Medical Equipment Group · Sep 2011