Cleared Special

K020671 - PSA4000 EEG MONITOR WITH FRONTAL PSI

K020671 is an FDA 510(k) clearance for PSA4000 EEG MONITOR WITH FRONTAL PSI, 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 217-day FDA review.

K020671 · Physiometrix, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
217d
Days
Class 2
Risk

K020671 is an FDA 510(k) clearance for the PSA4000 EEG MONITOR WITH FRONTAL PSI. 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 October 4, 2002 after a review of 217 days - an extended review 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. Standard predicate reliance. 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 - K020671

510(k) Number K020671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2002
Decision Date October 04, 2002
Days to Decision 217 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
69d slower than avg
Panel avg: 148d · This submission: 217d
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 K020671.
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
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
BIS ENGINE
K011834 · Aspect Medical Systems, Inc. · Jul 2001