Cleared Special

K062613 - BIS EEG MONITOR VIEW

K062613 is an FDA 510(k) clearance for BIS EEG MONITOR VIEW, manufactured by Aspect Medical Systems, Inc.. The device is a Class 2 Neurology device with product code OLW cleared through the Special 510(k) pathway after a 286-day FDA review.

K062613 · Aspect Medical Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
286d
Days
Class 2
Risk

K062613 is an FDA 510(k) clearance for the BIS EEG MONITOR VIEW. Classified as Index-generating Electroencephalograph Software (product code OLW), Class II - Special Controls.

Submitted by Aspect Medical Systems, Inc. (Norwood, US). The FDA issued a Cleared decision on June 18, 2007 after a review of 286 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 Aspect Medical Systems, Inc. devices

FDA 510(k) Submission Details - K062613

510(k) Number K062613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2006
Decision Date June 18, 2007
Days to Decision 286 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
138d slower than avg
Panel avg: 148d · This submission: 286d
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 K062613.
SedLine Sedation Monitor
K172890 · Masimo Corporation · Jan 2018
MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K061907 · Ge Healthcare · Mar 2008
BIS EEG VISTA MONITOR SYSTEM AND BISX
K072286 · Aspect Medical Systems, Inc. · Nov 2007
SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842
K060900 · Spacelabs Medical, Inc. · Jun 2006
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