# DEN200011: Masimo SafetyNet

- Pathway: De Novo (Direct)
- Applicant: Masimo Corporation
- Decided: Mar 31, 2023 after 1,136 days
- Product code: QVT (Monitor For Opioid Induced Impairment Of Oxygenation)
- Device class: 2
- Regulation: 21 CFR 868.2250
- 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 Masimo SafetyNet Opioid System is intended to monitor and alarm when a patient may be experiencing an opioid induced impairment of oxygenation. The Masimo SafetyNet Opioid System is indicated for the non-invasive continuous monitoring of individuals 15 years and older for the identification of when they may be experiencing a substance induced impairment of oxygenation (e.g., opioid induced respiratory depression (OIRD) caused by oral or injectable opioids) in hospital and home environments.

Source page: https://510kreport.com/device/DEN200011
Methodology: https://510kreport.com/methodology