Cleared Traditional

K081871 - UNIVERSAL ELECTRODES

K081871 is an FDA 510(k) clearance for UNIVERSAL ELECTRODES, manufactured by Neurometrix, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K081871 · Neurometrix, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
90d
Days
Class 2
Risk

K081871 is an FDA 510(k) clearance for the UNIVERSAL ELECTRODES. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Neurometrix, Inc. (Waltham, US). The FDA issued a Cleared decision on September 29, 2008 after a review of 90 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 Neurometrix, Inc. devices

FDA 510(k) Submission Details - K081871

510(k) Number K081871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2008
Decision Date September 29, 2008
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
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 213
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K081871.
BIS CLICK SENSOR/CABLE
K091854 · Aspect Medical Systems, Inc. · Jul 2009
WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP
K082065 · Well-Life Healthcare Limited · Apr 2009
GE ENTROPY SENSOR
K082540 · Ge Healthcare · Nov 2008
GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)
K062580 · Ge Healthcare · Dec 2007
ZIPPREP ELECTRODE
K070069 · Aspect Medical Systems, Inc. · Feb 2007
BIS BILATERAL SENSOR
K062692 · Aspect Medical Systems, Inc. · Dec 2006