Cleared Special

K002837 - BIS ENGINE

K002837 is an FDA 510(k) clearance for BIS ENGINE, manufactured by Aspect Medical Systems, Inc.. The device is a Class 2 Neurology device with product code OLW cleared through the Special 510(k) pathway after a 7-day FDA review.

K002837 · Aspect Medical Systems, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Sep 2000
Decision
7d
Days
Class 2
Risk

K002837 is an FDA 510(k) clearance for the BIS ENGINE. Classified as Index-generating Electroencephalograph Software (product code OLW), Class II - Special Controls.

Submitted by Aspect Medical Systems, Inc. (Newton, US). The FDA issued a Cleared decision on September 19, 2000 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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 - K002837

510(k) Number K002837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2000
Decision Date September 19, 2000
Days to Decision 7 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
141d faster than avg
Panel avg: 148d · This submission: 7d
Pathway characteristics
Modification to existing cleared device.

OLW Device Classification - Class 2, Special Controls

Product Code OLW Index-generating Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electrical Activity Of The Brain By Transformation Of Electroencephalograph Signals Into A Dimensionless Index Number For Use And Interpretation By A Qualified User.
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 - OLW Index-generating Electroencephalograph Software

All 25
Devices cleared under the same product code (OLW) and FDA review panel - the closest regulatory comparables to K002837.
BIS/EEG MODULE
K012466 · General Electric Medical Systems Information Techn · Oct 2001
BIS ENGINE
K011834 · Aspect Medical Systems, Inc. · Jul 2001
EEG MIS MONITOR MODEL # A-2000
K011534 · Aspect Medical Systems, Inc. · Jun 2001
A-2000 EEG MONITOR WITH BIS
K974496 · Aspect Medical Systems, Inc. · Feb 1998
SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE
K973596 · Spacelabs Medical, Inc. · Feb 1998
A-1000 EEG MONITOR AND A-1050 EEG MONITOR
K963644 · Aspect Medical Systems, Inc. · Oct 1996