# DEN200076: ORi

- Pathway: De Novo (Direct)
- Applicant: Masimo Corporation
- Decided: Oct 12, 2023 after 1,025 days
- Product code: QWE (Hyperoxia Monitoring Device Adjunct To Pulse Oximetry)
- Device class: 2
- Regulation: 21 CFR 870.2720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The ORi feature is intended to be used in patients undergoing surgery as an adjunct to SpO2 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.

Source page: https://510kreport.com/device/DEN200076
Methodology: https://510kreport.com/methodology