Is ORi FDA authorized?

FDA's records list DEN200076 for ORi from Masimo Corporation: De Novo, decision date Oct 12, 2023. The De Novo pathway means the device was granted marketing authorization, not approved.

What product code is DEN200076?

QWE: Hyperoxia Monitoring Device Adjunct To Pulse Oximetry, regulated under 21 CFR 870.2720, class 2.

FDA De Novo · Masimo

DEN200076: ORi (Masimo Corporation)

Masimo Corporation received FDA De Novo DEN200076 for ORi, with a decision date of Oct 12, 2023.

Prescription or OTC: Unknown (no FDA document we parsed states it).

FDA record for DEN200076 FDA decision summary (PDF)

FDA facts

Official fields for DEN200076
FDA number	DEN200076
Pathway	De Novo
Applicant	Masimo Corporation
Device name	ORi
Product code	QWE: Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
Regulation (21 CFR)	870.2720
Device class	Class 2
Date received	Dec 21, 2020
Decision date	Oct 12, 2023
Decision	Unknown (DENG)

Source: openFDA device 510(k) data, data through Oct 26, 2026.

Indications for use parsed from FDA documents

The ORi feature is intended to be used in patients undergoing surgery as an adjunct to Sp02 for increased monitoring resolution of elevated hemoglobin oxygen saturation levels (e.g., due to the administration of supplemental oxygen). The ORi feature is indicated for the monitoring of hemoglobin oxygen saturation levels in patients 18 years and older (adults and transitional adolescents) on supplemental oxygen during no-motion conditions perioperatively in hospital environments.

Extracted automatically from FDA's decision summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.

Predicates parsed from FDA documents

A De Novo request is for a new type of device with no legally marketed predicate. When FDA grants it, the device can serve as a predicate for later 510(k) submissions.

ChatPPG interpretation

A granted De Novo request authorizes a new type of low- to moderate-risk device and creates a classification regulation for it (here 21 CFR 870.2720). The usual wording is "granted" or "authorized", not "approved". See FDA cleared vs approved.

Product code QWE is "Hyperoxia Monitoring Device Adjunct To Pulse Oximetry", class 2, 21 CFR 870.2720. FDA's 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."

Our labels for filtering: claim SpO2 / pulse oximetry, sensor Finger PPG. These are heuristics, not FDA fields.