Cleared Special

K052981 - BIS EEG MONITOR

K052981 is an FDA 510(k) clearance for BIS EEG MONITOR, 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 8-day FDA review.

K052981 · Aspect Medical Systems, Inc. · Neurology device
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Nov 2005
Decision
8d
Days
Class 2
Risk

K052981 is an FDA 510(k) clearance for the BIS EEG MONITOR, MODEL BISX4. 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 November 1, 2005 after a review of 8 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 - K052981

510(k) Number K052981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2005
Decision Date November 01, 2005
Days to Decision 8 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d faster than avg
Panel avg: 148d · This submission: 8d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

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 Consultant

Intertek Testing Services
DANIEL W LEHTONEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K052981.
BIS EEG VISTA MONITOR SYSTEM AND BISX
K072286 · Aspect Medical Systems, Inc. · Nov 2007
BIS EEG MONITOR VIEW
K062613 · Aspect Medical Systems, Inc. · Jun 2007
SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842
K060900 · Spacelabs Medical, Inc. · Jun 2006
BIS EEG MONITOR, MODEL A-3000
K052362 · Aspect Medical Systems, Inc. · Sep 2005
DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES
K052145 · Ge Healthcare · Aug 2005
DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K050835 · Ge Healthcare · May 2005