Cleared Abbreviated

K040595 - ALICE 5

K040595 is the FDA 510(k) clearance for ALICE 5 by Respironics, Inc.. It is a Class 2 Neurology device (product code OLZ) cleared through the Abbreviated 510(k) pathway after a 10-day FDA review.

K040595 · Respironics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
10d
Days
Class 2
Risk

K040595 is an FDA 510(k) clearance for the ALICE 5. Classified as Automatic Event Detection Software For Polysomnograph With Electroencephalograph (product code OLZ), Class II - Special Controls.

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on March 18, 2004 after a review of 10 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Respironics, Inc. devices

Submission Details

510(k) Number K040595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2004
Decision Date March 18, 2004
Days to Decision 10 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d faster than avg
Panel avg: 148d · This submission: 10d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

Device Classification

Product Code OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Automatically Mark Electroencephalograph And Polysomongraph Signals In Order To Aid In Identification Of Such Events And Annotation Of Prolonged Psg Traces; Automatically Calculate Simple Measures Obtained From Recorded Signals (e.g. Magnitude, Time, Frequency And Simple Statistical Measures Of Marked Events); All Output Subject To Verification By 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 Consultant

Entela, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph

All 18
Devices cleared under the same product code (OLZ) and FDA review panel - the closest regulatory comparables to K040595.
Esprit Nova
K182227 · Neurozone Msh Incorporated · Jan 2019
NicoletOne
K173366 · Natus Neurology Incorporated · Jul 2018
Sleepware G3
K142988 · Respironics, Inc. · Mar 2015
MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM
K891383 · Oxford Medilog, Inc. · Jun 1989
MODEL MPA MULTI PARAMETER ANALYSIS MONITORING SYS.
K871990 · Oxford Medilog, Inc. · Oct 1987