Cleared Traditional

K080276 - SELF-ADHESIVE ELECTRODES

K080276 is an FDA 510(k) clearance for SELF-ADHESIVE ELECTRODES, manufactured by Cathay Health Care Equipment Manufacturing, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K080276 · Cathay Health Care Equipment Manufacturing, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
182d
Days
Class 2
Risk

K080276 is an FDA 510(k) clearance for the SELF-ADHESIVE ELECTRODES. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Cathay Health Care Equipment Manufacturing, Inc. (La Mirada, US). The FDA issued a Cleared decision on August 4, 2008 after a review of 182 days - an extended review cycle.

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 Cathay Health Care Equipment Manufacturing, Inc. devices

FDA 510(k) Submission Details - K080276

510(k) Number K080276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2008
Decision Date August 04, 2008
Days to Decision 182 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
34d slower than avg
Panel avg: 148d · This submission: 182d
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 195
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K080276.
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