Not Cleared Direct

DEN200076 - ORi (FDA 510(k) Clearance)

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

DEN200076 · Masimo Corporation · Anesthesiology device
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Oct 2023
Decision
1025d
Days
Class 2
Risk

DEN200076 is an FDA 510(k) submission (not cleared) for the ORi. Classified as Hyperoxia Monitoring Device Adjunct To Pulse Oximetry (product code QWE), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Not Cleared (DENG) decision on October 12, 2023 after a review of 1025 days.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2720 - 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 1025 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 DEN200076 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 21, 2020
Decision Date October 12, 2023
Days to Decision 1025 days
Submission Type Direct
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
886d slower than avg
Panel avg: 139d · This submission: 1025d
Pathway characteristics

Device Classification

Product Code QWE Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2720
Definition A Hyperoxia Monitoring Device Adjunct To Pulse Oximetry Is A Device That Monitors Elevated Hemoglobin Oxygen Saturation Levels As An Adjunct To Arterial Oxygen Saturation Monitoring.
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.