Cleared Special

K142470 - E-Shield Multi-paried Subdermal Needle Electrodes

K142470 is an FDA 510(k) clearance for E-Shield Multi-paried Subdermal Needle ..., manufactured by Neuroinvent, Inc.. The device is a Class 2 Neurology device with product code GXZ cleared through the Special 510(k) pathway after a 63-day FDA review.

K142470 · Neuroinvent, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
63d
Days
Class 2
Risk

K142470 is an FDA 510(k) clearance for the E-Shield Multi-paried Subdermal Needle Electrodes. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Neuroinvent, Inc. (Cupertino, US). The FDA issued a Cleared decision on November 5, 2014 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1350 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K142470

510(k) Number K142470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2014
Decision Date November 05, 2014
Days to Decision 63 days
Submission Type Special
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
86d faster than avg
Panel avg: 149d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

GXZ Device Classification - Class 2, Special Controls

Product Code GXZ Electrode, Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1350
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 - GXZ Electrode, Needle

All 52
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K142470.
Spes Medica Subdermal Needle Electrodes
K192603 · Spes Medica Srl · Nov 2019
PressOn Electrode Headset
K190801 · Rhythmlink International, LLC · Jul 2019
DMS Disposable Subdermal Needle Electrodes
K161566 · Daehan Medical Systems Co., Ltd. · Dec 2016
E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES
K140200 · Neuroinvent, Inc. · Jul 2014
MR CONDITIONAL PRESSON ELECTRODE
K130220 · Rhythmlink International, LLC · Jul 2013
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,
K130136 · Technomed Europe · Jul 2013
K142470 · E-Shield Multi-paried Subdermal Needle Electrodes
Download PDF FDA Summary Neuroinvent, Inc.