Cleared Traditional

K120494 - DISPOSABLE ADHESIVE SURFACE ELECTRODE

K120494 is an FDA 510(k) clearance for DISPOSABLE ADHESIVE SURFACE ELECTRODE, manufactured by Spes Medica Srl. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K120494 · Spes Medica Srl · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
115d
Days
Class 2
Risk

K120494 is an FDA 510(k) clearance for the DISPOSABLE ADHESIVE SURFACE ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Spes Medica Srl (Battipaglia, IT). The FDA issued a Cleared decision on June 11, 2012 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Spes Medica Srl devices

FDA 510(k) Submission Details - K120494

510(k) Number K120494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2012
Decision Date June 11, 2012
Days to Decision 115 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 148d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 185
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K120494.
BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES)
K143506 · Covidien · Apr 2015
GARMENT ELECTRODES
K141076 · Shenzhen Dongdixin Technology Co., Ltd. · Nov 2014
DYNATRON PELTIER THERMOSTIM PROBE
K132057 · Dynatronics Corp. · Jan 2014
LONG LIFE PADTM
K120516 · Omron Healthcare, Inc. · May 2012
NEUROTECH RECOVERY
K112934 · Bio-Medical Research, Ltd. · Jan 2012
LIFECARE CONDUCTIVE GARMENTS
K103719 · Everyway Medical Instruments Co.,Ltd · Aug 2011