Cleared Special

K040183 - BISX

K040183 is an FDA 510(k) clearance for BISX, 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 29-day FDA review.

K040183 · Aspect Medical Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
29d
Days
Class 2
Risk

K040183 is an FDA 510(k) clearance for the BISX. Classified as Index-generating Electroencephalograph Software (product code OLW), Class II - Special Controls.

Submitted by Aspect Medical Systems, Inc. (Lafayette, US). The FDA issued a Cleared decision on February 25, 2004 after a review of 29 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 - K040183

510(k) Number K040183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2004
Decision Date February 25, 2004
Days to Decision 29 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
119d faster than avg
Panel avg: 148d · This submission: 29d
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

Entela, Inc.
NED DEVINE

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 K040183.
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
EEG MONITOR WITH BIS, MODEL A-2000
K030267 · Aspect Medical Systems, Inc. · Jan 2004
MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000
K031694 · Aspect Medical Systems, Inc. · Aug 2003
DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES
K023459 · Datex-Ohmeda · Jan 2003