Cleared Special

K011534 - EEG MIS MONITOR MODEL # A-2000

Also marketed or referenced as:
BIS ENGINE

K011534 is an FDA 510(k) clearance for EEG MIS MONITOR MODEL # A-2000, 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 28-day FDA review.

K011534 · Aspect Medical Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
28d
Days
Class 2
Risk

K011534 is an FDA 510(k) clearance for the EEG MIS MONITOR MODEL # A-2000. 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 June 15, 2001 after a review of 28 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 - K011534

510(k) Number K011534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2001
Decision Date June 15, 2001
Days to Decision 28 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
120d faster than avg
Panel avg: 148d · This submission: 28d
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 K011534.
DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES
K013389 · Datex-Ohmeda · Jan 2002
BIS/EEG MODULE
K012466 · General Electric Medical Systems Information Techn · Oct 2001
BIS ENGINE
K011834 · Aspect Medical Systems, Inc. · Jul 2001
BIS ENGINE
K002837 · Aspect Medical Systems, Inc. · Sep 2000
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