Cleared Special

K002734 - ASPECT MEDICAL SYTEMS EEG ENHANCED BIS ...

K002734 is an FDA 510(k) clearance for ASPECT MEDICAL SYTEMS EEG ENHANCED BIS ..., 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 13-day FDA review.

K002734 · Aspect Medical Systems, Inc. · Neurology device
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Sep 2000
Decision
13d
Days
Class 2
Risk

K002734 is an FDA 510(k) clearance for the ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106. 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 September 14, 2000 after a review of 13 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 - K002734

510(k) Number K002734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2000
Decision Date September 14, 2000
Days to Decision 13 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
135d faster than avg
Panel avg: 148d · This submission: 13d
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 K002734.
KM-30 TENS ELECTRODE
K010543 · Katecho, Inc. · May 2001
KM-10 TENS ELECTRODE
K000870 · Katecho, Inc. · Nov 2000
ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110
K001980 · Aspect Medical Systems, Inc. · Sep 2000
ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076
K994330 · Aspect Medical Systems, Inc. · Jan 2000
EEG ELECTRODES
K962283 · Teca, Inc. · Dec 1996
ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR
K961821 · Aspect Medical Systems, Inc. · Oct 1996