Cleared Traditional

K072286 - BIS EEG VISTA MONITOR SYSTEM AND BISX

K072286 is an FDA 510(k) clearance for BIS EEG VISTA MONITOR SYSTEM AND BISX, manufactured by Aspect Medical Systems, Inc.. The device is a Class 2 Neurology device with product code OLW cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K072286 · Aspect Medical Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
96d
Days
Class 2
Risk

K072286 is an FDA 510(k) clearance for the BIS EEG VISTA MONITOR SYSTEM AND BISX. 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 November 20, 2007 after a review of 96 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 Aspect Medical Systems, Inc. devices

FDA 510(k) Submission Details - K072286

510(k) Number K072286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2007
Decision Date November 20, 2007
Days to Decision 96 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
52d faster than avg
Panel avg: 148d · This submission: 96d
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 K072286.
NeuroSENSE Monitoring System, Model NS-901
K202621 · Neurowave Systems, Inc. · Aug 2021
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 MONITOR VIEW
K062613 · Aspect Medical Systems, Inc. · Jun 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