Cleared Traditional

K143506 - BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES)

Also marketed or referenced as:
BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES BIS QUATRO SENSOR BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES) BIS EXTEND SENSOR BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES) BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL (4 ELECTRODES)

K143506 is an FDA 510(k) clearance for BIS STANDARD SENSOR, manufactured by Covidien. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K143506 · Covidien · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
127d
Days
Class 2
Risk

K143506 is an FDA 510(k) clearance for the BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES). Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Covidien (Boulder, US). The FDA issued a Cleared decision on April 16, 2015 after a review of 127 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 Covidien devices

FDA 510(k) Submission Details - K143506

510(k) Number K143506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2014
Decision Date April 16, 2015
Days to Decision 127 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
21d faster than avg
Panel avg: 148d · This submission: 127d
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 228
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K143506.
Electrodes with silver conductive
K171721 · Shenzhen Konmed Technology Co., Ltd. · Jan 2018
MR Conditional Cup Electrode, MR Conditional Webb Electrode
K172503 · Rhythmlink International, LLC · Dec 2017
Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes
K153019 · Bio Protech, Inc. · Mar 2016
ASCEND ELECTRODE
K140586 · Neurometrix, Inc. · Nov 2014
CUTANEOUS ELECTRODES
K142099 · Bio Protech, Inc. · Nov 2014
GARMENT ELECTRODES
K141076 · Shenzhen Dongdixin Technology Co., Ltd. · Nov 2014