Cleared Traditional

K143506 - BIS STANDARD SENSOR

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 the FDA 510(k) clearance for BIS STANDARD SENSOR by Covidien. It is a Class 2 Neurology device (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

Submission Details

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.

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 105
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K143506.
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
SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE
K100418 · Covidien · Sep 2010
DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE
K091762 · Covidien · Dec 2009
GE ENTROPY SENSOR
K082540 · Ge Healthcare · Nov 2008