Cleared Traditional

K031694 - MODIFICATION TO EEG MONITOR WITH BIS

K031694 is an FDA 510(k) clearance for MODIFICATION TO EEG MONITOR WITH BIS, manufactured by Aspect Medical Systems, Inc.. The device is a Class 2 Neurology device with product code OLW cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K031694 · Aspect Medical Systems, Inc. · Neurology device
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Aug 2003
Decision
88d
Days
Class 2
Risk

K031694 is an FDA 510(k) clearance for the MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000. 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 August 29, 2003 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aspect Medical Systems, Inc. devices

FDA 510(k) Submission Details - K031694

510(k) Number K031694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2003
Decision Date August 29, 2003
Days to Decision 88 days
Submission Type Traditional
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
60d faster than avg
Panel avg: 148d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K031694.
DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K050835 · Ge Healthcare · May 2005
BISX
K040183 · Aspect Medical Systems, Inc. · Feb 2004
EEG MONITOR WITH BIS, MODEL A-2000
K030267 · Aspect Medical Systems, Inc. · Jan 2004
DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES
K023459 · Datex-Ohmeda · Jan 2003
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