Cleared Special

K051874 - SEDLINE SEDATION MONITOR WITH FRONTAL P...

K051874 is an FDA 510(k) clearance for SEDLINE SEDATION MONITOR WITH FRONTAL P..., manufactured by Physiometrix, Inc.. The device is a Class 2 Neurology device with product code OLW cleared through the Special 510(k) pathway after a 53-day FDA review.

K051874 · Physiometrix, Inc. · Neurology device
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Sep 2005
Decision
53d
Days
Class 2
Risk

K051874 is an FDA 510(k) clearance for the SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET. Classified as Index-generating Electroencephalograph Software (product code OLW), Class II - Special Controls.

Submitted by Physiometrix, Inc. (North Billerica, US). The FDA issued a Cleared decision on September 2, 2005 after a review of 53 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 Physiometrix, Inc. devices

FDA 510(k) Submission Details - K051874

510(k) Number K051874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2005
Decision Date September 02, 2005
Days to Decision 53 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
95d faster than avg
Panel avg: 148d · This submission: 53d
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 29
Devices cleared under the same product code (OLW) and FDA review panel - the closest regulatory comparables to K051874.
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K052145 · Ge Healthcare · Aug 2005
DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K050835 · Ge Healthcare · May 2005
BISX
K040183 · Aspect Medical Systems, Inc. · Feb 2004