Cleared Abbreviated

K190416 - Dome Electrode

K190416 is the FDA 510(k) clearance for Dome Electrode by Coapt, LLC. It is a Class 2 Neurology device (product code GXY) cleared through the Abbreviated 510(k) pathway after a 42-day FDA review.

K190416 · Coapt, LLC · Neurology device
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Optimized for regulatory review, auditing and printing
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.

View all Coapt, LLC devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 148d · 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

All 141
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