Cleared Traditional

K010965 - A-LINE AEP MONITOR

K010965 is an FDA 510(k) clearance for A-LINE AEP MONITOR, manufactured by Alaris Medical Systems, Inc.. The device is a Class 2 Neurology device with product code OLW cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K010965 · Alaris Medical Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
86d
Days
Class 2
Risk

K010965 is an FDA 510(k) clearance for the A-LINE AEP MONITOR. Classified as Index-generating Electroencephalograph Software (product code OLW), Class II - Special Controls.

Submitted by Alaris Medical Systems, Inc. (San Diego, US). The FDA issued a Cleared decision on June 27, 2001 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Alaris Medical Systems, Inc. devices

FDA 510(k) Submission Details - K010965

510(k) Number K010965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2001
Decision Date June 27, 2001
Days to Decision 86 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
62d faster than avg
Panel avg: 148d · This submission: 86d
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 33
Devices cleared under the same product code (OLW) and FDA review panel - the closest regulatory comparables to K010965.
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
EEG MIS MONITOR MODEL # A-2000
K011534 · Aspect Medical Systems, Inc. · Jun 2001
BIS ENGINE
K002837 · Aspect Medical Systems, Inc. · Sep 2000
MODEL 4000 EEG MONITOR WITH PSI (PSA4000)
K001069 · Physiometrix, Inc. · Jun 2000