Cleared Traditional

K963631 - SLEEP STUDY ANALYSIS (SSA) VERSION 96.10

K963631 is an FDA 510(k) clearance for SLEEP STUDY ANALYSIS (SSA) VERSION 96.10, manufactured by Omega Results. The device is a Class 2 Neurology device with product code OLZ cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K963631 · Omega Results · Neurology device
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Apr 1997
Decision
203d
Days
Class 2
Risk

K963631 is an FDA 510(k) clearance for the SLEEP STUDY ANALYSIS (SSA) VERSION 96.10. Classified as Automatic Event Detection Software For Polysomnograph With Electroencephalograph (product code OLZ), Class II - Special Controls.

Submitted by Omega Results (Dallas, US). The FDA issued a Cleared decision on April 2, 1997 after a review of 203 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. 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 Omega Results devices

FDA 510(k) Submission Details - K963631

510(k) Number K963631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1996
Decision Date April 02, 1997
Days to Decision 203 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 148d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLZ Device Classification - Class 2, Special Controls

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 Peers - OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph

All 22
Devices cleared under the same product code (OLZ) and FDA review panel - the closest regulatory comparables to K963631.
NicoletOne
K173366 · Natus Neurology Incorporated · Jul 2018
Sleepware G3
K142988 · Respironics, Inc. · Mar 2015
ALICE 5
K040595 · Respironics, Inc. · Mar 2004
MEDILOG VISION
K961636 · Oxford Instruments, Plc. · Jan 1997
SENSORMEDICS 4000 SERIES SLEEP SYSTEM
K915856 · Sensor Medics Corp. · Oct 1992
MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM
K891383 · Oxford Medilog, Inc. · Jun 1989