Cleared Special

K062692 - BIS BILATERAL SENSOR

K062692 is an FDA 510(k) clearance for BIS BILATERAL SENSOR, manufactured by Aspect Medical Systems, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Special 510(k) pathway after a 93-day FDA review.

K062692 · Aspect Medical Systems, Inc. · Neurology device
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Dec 2006
Decision
93d
Days
Class 2
Risk

K062692 is an FDA 510(k) clearance for the BIS BILATERAL SENSOR. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Aspect Medical Systems, Inc. (Newton, US). The FDA issued a Cleared decision on December 13, 2006 after a review of 93 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Aspect Medical Systems, Inc. devices

FDA 510(k) Submission Details - K062692

510(k) Number K062692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2006
Decision Date December 13, 2006
Days to Decision 93 days
Submission Type Special
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
55d faster than avg
Panel avg: 148d · This submission: 93d
Pathway characteristics
Modification to existing cleared device.

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 184
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K062692.
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
XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES
K061269 · Excel Tech. , Ltd. · Aug 2006
AMBU NEUROLINE GROUND
K051529 · Ambu, Inc. · Aug 2005
VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART
K041953 · Conmedcorp · Aug 2004