Cleared Special

K994330 - ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076

K994330 is an FDA 510(k) clearance for ASPECT MEDICAL SYSTEMS EEG 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 26-day FDA review.

K994330 · Aspect Medical Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
26d
Days
Class 2
Risk

K994330 is an FDA 510(k) clearance for the ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Aspect Medical Systems, Inc. (Natick, US). The FDA issued a Cleared decision on January 18, 2000 after a review of 26 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 - K994330

510(k) Number K994330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1999
Decision Date January 18, 2000
Days to Decision 26 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
123d faster than avg
Panel avg: 149d · This submission: 26d
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 338
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K994330.
ULTRASTIM ELECTRODE, MODEL US4040
K000947 · Axelgaard Mfg. Co., Ltd. · Jun 2000
MODEL 4300 PSARRAY EEG ELECTRODE SET
K001055 · Physiometrix, Inc. · May 2000
QUIK-CAP
K000865 · Neuroscan · Apr 2000
ULTRA-GARMENT ELECTRODE
K993130 · Newwave Medical, LLC · Dec 1999
TENS/FES/NMES ELECTRODES
K983097 · Uni-Patch, Inc. · Sep 1999
CUTANEOUS (BAR) ELECTRODE
K991769 · Neuro Supplies, Inc. · Aug 1999