Anesthesiology · De Novo · 2023
Masimo SafetyNet
Masimo Corporation. Granted by FDA on 31 March 2023 under submission DEN200011, product code QVT (monitor for opioid induced impairment of oxygenation). What FDA's record says, in FDA's words.
Device record · DEN200011
- Device. Masimo SafetyNetDEVICE
- Company. Masimo CorporationCOMPANY
- Decision. 31 March 2023, De NovoDECISION
- Panel. AnesthesiologyPANEL
- Product code. QVT, Monitor For Opioid Induced Impairment Of OxygenationCODE
- Regulation. 21 CFR 868.2250, Class IIREG
- Source. FDA database entry · decision document (11 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
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.
The product code's definition, from FDA's classification record. 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
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QVT. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QVT, in Anesthesiology, or granted in 2023. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.