Cleared Traditional

K003038 - AGILENT COMPONENT MONITORING SYSTEM

K003038 is the FDA 510(k) clearance for AGILENT COMPONENT MONITORING SYSTEM by Agilent Technologies Deutschland GmbH. It is a Class 2 Neurology device (product code OLW) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K003038 · Agilent Technologies Deutschland GmbH · Neurology device
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Dec 2000
Decision
77d
Days
Class 2
Risk

K003038 is an FDA 510(k) clearance for the AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODE.... Classified as Index-generating Electroencephalograph Software (product code OLW), Class II - Special Controls.

Submitted by Agilent Technologies Deutschland GmbH (Boeblingen,, DE). The FDA issued a Cleared decision on December 15, 2000 after a review of 77 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 Agilent Technologies Deutschland GmbH devices

Submission Details

510(k) Number K003038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2000
Decision Date December 15, 2000
Days to Decision 77 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 148d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 13
Devices cleared under the same product code (OLW) and FDA review panel - the closest regulatory comparables to K003038.
DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K050835 · Ge Healthcare · May 2005
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
SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE
K973596 · Spacelabs Medical, Inc. · Feb 1998