Cleared Abbreviated

K172703 - Disposable Snap Electrode

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

K172703 · Embla Systems · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 148d · This submission: 67d
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 142
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K172703.
S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D
K173186 · Everyway Medical Instruments Co.,Ltd · Feb 2018
Electrodes with snap / Electrodes with pigtail
K171722 · Shenzhen Konmed Technology Co., Ltd. · Jan 2018
Electrodes with silver conductive
K171721 · Shenzhen Konmed Technology Co., Ltd. · Jan 2018
BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES)
K143506 · Covidien · Apr 2015
LONG LIFE PADTM
K120516 · Omron Healthcare, Inc. · May 2012
SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE
K100418 · Covidien · Sep 2010