Cleared Abbreviated

K190416 - Dome Electrode (FDA 510(k) Clearance)

Class II Neurology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K190416 · Coapt, LLC · Neurology device
Apr 2019
Decision
42d
Days
Class 2
Risk

K190416 is an FDA 510(k) clearance for the Dome Electrode. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Coapt, LLC (Chicago, US). The FDA issued a Cleared decision on April 4, 2019 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - the FDA neurology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

Submission Details

510(k) Number K190416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2019
Decision Date April 04, 2019
Days to Decision 42 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 163d · This submission: 42d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 Neurology devices follow this clearance model.

Regulatory Peers - GXY Electrode, Cutaneous

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