Cleared Traditional

K202142 - Sleepware G3 (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202142 · Respironics, Inc. · Neurology device
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Oct 2020
Decision
90d
Days
Class 2
Risk

K202142 is an FDA 510(k) clearance for the Sleepware G3. 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 October 29, 2020 after a review of 90 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 Respironics, Inc. devices

Submission Details

510(k) Number K202142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2020
Decision Date October 29, 2020
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph

All 35
Devices cleared under the same product code (OLZ) and FDA review panel - the closest regulatory comparables to K202142.
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