Cleared Abbreviated

K172703 - Disposable Snap Electrode

K172703 is an FDA 510(k) clearance for Disposable Snap Electrode, manufactured by Embla Systems. The device is a Class 2 Neurology device with product code GXY cleared through the Abbreviated 510(k) pathway after a 67-day FDA review.

K172703 · Embla Systems · Neurology device
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Nov 2017
Decision
67d
Days
Class 2
Risk

K172703 is an FDA 510(k) clearance for the Disposable Snap Electrode. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Embla Systems (Kanata, CA). The FDA issued a Cleared decision on November 13, 2017 after a review of 67 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 Embla Systems devices

FDA 510(k) Submission Details - K172703

510(k) Number K172703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2017
Decision Date November 13, 2017
Days to Decision 67 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
81d faster than avg
Panel avg: 148d · This submission: 67d
Pathway characteristics
Standards-based clearance path.

GXY Device Classification - Class 2, Special Controls

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 290
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K172703.
Ives MR Conditional Cup Electrode
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Adhesive Electrodes
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MR Conditional Cup Electrode, MR Conditional Webb Electrode
K172503 · Rhythmlink International, LLC · Dec 2017
Ceribell Instant EEG Headband
K171459 · Ceribell, Inc. · Aug 2017
Adhesive Electrodes
K170744 · Reno Medical , Ltd. · May 2017
WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts
K162460 · Wavi Co. · Apr 2017