Not Cleared Direct

DEN200011 - Masimo SafetyNet (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN200011 · Masimo Corporation · Anesthesiology device
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Mar 2023
Decision
1136d
Days
Class 2
Risk

DEN200011 is an FDA 510(k) submission (not cleared) for the Masimo SafetyNet. Classified as Monitor For Opioid Induced Impairment Of Oxygenation (product code QVT), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Not Cleared (DENG) decision on March 31, 2023 after a review of 1136 days.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2250 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 1136 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN200011 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 19, 2020
Decision Date March 31, 2023
Days to Decision 1136 days
Submission Type Direct
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
997d slower than avg
Panel avg: 139d · This submission: 1136d
Pathway characteristics

Device Classification

Product Code QVT Monitor For Opioid Induced Impairment Of Oxygenation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2250
Definition A Monitor For Opioid Induced Impairment Of Oxygenation Is A Device That Uses Sensor Hardware And Software Algorithms To Detect Desaturations Of Arterial Oxygen Saturation Resulting From Opioid Overdose
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 Anesthesiology devices follow this clearance model.