Cleared Traditional

K062580 - GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)

K062580 is an FDA 510(k) clearance for GE ENTROPY SENSOR (REFM1038681) AND GE ..., manufactured by Ge Healthcare. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 477-day FDA review.

K062580 · Ge Healthcare · Neurology device
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Dec 2007
Decision
477d
Days
Class 2
Risk

K062580 is an FDA 510(k) clearance for the GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784). Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Ge Healthcare (Needham, US). The FDA issued a Cleared decision on December 21, 2007 after a review of 477 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Ge Healthcare devices

FDA 510(k) Submission Details - K062580

510(k) Number K062580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2006
Decision Date December 21, 2007
Days to Decision 477 days
Submission Type Traditional
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
329d slower than avg
Panel avg: 148d · This submission: 477d
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 293
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K062580.
UNIVERSAL ELECTRODES
K083818 · Neurometrix, Inc. · Jan 2009
GE ENTROPY SENSOR
K082540 · Ge Healthcare · Nov 2008
UNIVERSAL ELECTRODES
K081871 · Neurometrix, Inc. · Sep 2008
ZIPPREP ELECTRODE
K070069 · Aspect Medical Systems, Inc. · Feb 2007
BIS BILATERAL SENSOR
K062692 · Aspect Medical Systems, Inc. · Dec 2006
XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES
K061269 · Excel Tech. , Ltd. · Aug 2006