FDA De Novo · Masimo
DEN200011: Masimo SafetyNet (Masimo Corporation)
Masimo Corporation received FDA De Novo DEN200011 for Masimo SafetyNet, with a decision date of Mar 31, 2023.
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | DEN200011 |
|---|---|
| Pathway | De Novo |
| Applicant | Masimo Corporation |
| Device name | Masimo SafetyNet |
| Product code | QVT: Monitor For Opioid Induced Impairment Of Oxygenation |
| Regulation (21 CFR) | 868.2250 |
| Device class | Class 2 |
| Date received | Feb 19, 2020 |
| Decision date | Mar 31, 2023 |
| Decision | Unknown (DENG) |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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.
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 868.2250). The usual wording is "granted" or "authorized", not "approved". See FDA cleared vs approved.
Product code QVT is "Monitor For Opioid Induced Impairment Of Oxygenation", class 2, 21 CFR 868.2250. FDA's 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"
Our labels for filtering: claim SpO2 / pulse oximetry, sensor Finger PPG. These are heuristics, not FDA fields.