Cleared Traditional

K013389 - DATEX-OHMEDA S/5 BIS MODULE

K013389 is an FDA 510(k) clearance for DATEX-OHMEDA S/5 BIS MODULE, manufactured by Datex-Ohmeda. The device is a Class 2 Neurology device with product code OLW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K013389 · Datex-Ohmeda · Neurology device
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Jan 2002
Decision
90d
Days
Class 2
Risk

K013389 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES. Classified as Index-generating Electroencephalograph Software (product code OLW), Class II - Special Controls.

Submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on January 10, 2002 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Datex-Ohmeda devices

FDA 510(k) Submission Details - K013389

510(k) Number K013389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2001
Decision Date January 10, 2002
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
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 K013389.
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
BIS/EEG MODULE
K012466 · General Electric Medical Systems Information Techn · Oct 2001
BIS ENGINE
K011834 · Aspect Medical Systems, Inc. · Jul 2001
EEG MIS MONITOR MODEL # A-2000
K011534 · Aspect Medical Systems, Inc. · Jun 2001