Cleared Special

EEG MIS MONITOR MODEL # A-2000 (K011534) - FDA 510(k) Clearance

Also marketed or referenced as:
BIS ENGINE

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 148d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 37
Devices cleared under the same product code (OLW) and FDA review panel - the closest regulatory comparables to K011534.
BIS™ Advance Monitoring System
K230693 · Covidien, LLC · Feb 2024
Brain Anesthesia Response Monitor (Bar Monitor)
K213273 · Cortical Dynamics , Ltd. · Sep 2023
Masimo SedLine Sedation Monitor and Accessories
K203113 · Masimo Corporation · Feb 2022
NeuroSENSE Monitoring System, Model NS-901
K202621 · Neurowave Systems, Inc. · Aug 2021
SedLine Sedation Monitor
K172890 · Masimo Corporation · Jan 2018