Cleared Special

K050835 - DATEX-OHMEDA S/5TM ENTROPY MODULE

K050835 is an FDA 510(k) clearance for DATEX-OHMEDA S/5TM ENTROPY MODULE, manufactured by Ge Healthcare. The device is a Class 2 Neurology device with product code OLW cleared through the Special 510(k) pathway after a 35-day FDA review.

K050835 · Ge Healthcare · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
35d
Days
Class 2
Risk

K050835 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES. Classified as Index-generating Electroencephalograph Software (product code OLW), Class II - Special Controls.

Submitted by Ge Healthcare (Needham, US). The FDA issued a Cleared decision on May 6, 2005 after a review of 35 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 Ge Healthcare devices

FDA 510(k) Submission Details - K050835

510(k) Number K050835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2005
Decision Date May 06, 2005
Days to Decision 35 days
Submission Type Special
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
113d faster than avg
Panel avg: 148d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

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 K050835.
BIS EEG MONITOR, MODEL BISX4
K052981 · Aspect Medical Systems, Inc. · Nov 2005
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
BISX
K040183 · Aspect Medical Systems, Inc. · Feb 2004
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