Masimo SafetyNet is an AI-enabled medical device from Masimo Corporation that the U.S. FDA granted through De Novo DEN200011 on March 31, 2023. Its lead review panel is Anesthesiology and its primary product code is QVT (Monitor For Opioid Induced Impairment Of Oxygenation).
See also FDA-cleared AI anesthesiology devices in 2023, all FDA AI clearances in 2023, top anesthesiology AI devices.
Key facts
| Submission number | DEN200011 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | Masimo Corporation |
| Lead review panel | Anesthesiology |
| Primary product code | QVT — Monitor For Opioid Induced Impairment Of Oxygenation |
| Applicant (openFDA) | Masimo Corporation |
| Applicant location | Irvine, CA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 868.2250 |
| Decision code | DENG |
| Submission type | Direct |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. Masimo SafetyNet went through this pathway (DEN200011).
openFDA lists it as a Class 2 device under 21 CFR 868.2250. Class II devices are moderate risk and are subject to general and special controls.
Product code QVT covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Masimo Corporation has 1 AI-enabled device on the list, and the Anesthesiology panel accounts for 30 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.