Identifiers
- 510(k) Number
- DEN200011 FDA 510(k)
- FDA Product Code
- QVT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.2250 FDA 510(k)
- Regulation Number
- 868.2250 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
The Masimo SafetyNet is a Monitor for Opioid-Induced Impairment of Oxygenation, classified under FDA regulation 868.2250 as a Class II device. It is designed to remotely monitor patients for signs of opioid-induced respiratory depression, providing continuous pulse oximetry and temperature measurements via tetherless SET® sensors. The system integrates real-time data transmission to enable clinical oversight beyond traditional hospital settings, supporting early intervention for at-risk patients.
Supplied as a cloud-based telehealth platform, the Masimo SafetyNet connects to Masimo pulse oximeters and temperature sensors, transmitting near-real-time vital signs to a central monitoring station. It is intended for single-use sensors (where applicable) and operates in both hospital and outpatient environments, though sterility and reuse instructions are not specified in the data. The system is FDA-cleared via 510(k) (K200011) and adheres to regulatory standards for remote patient monitoring, with no explicit MRI safety or size variations noted in the provided specifications.
Frequently asked questions
What is the Masimo SafetyNet designed to monitor in patients?
The Masimo SafetyNet is specifically designed to remotely monitor patients for opioid-induced respiratory depression. It continuously tracks pulse oximetry (oxygen saturation) and temperature via tetherless SET® sensors, allowing clinicians to detect early signs of impaired oxygenation in real time. This is particularly useful for patients at risk of respiratory depression due to opioid use, enabling proactive intervention before critical deterioration occurs.
How is the Masimo SafetyNet system supplied and where can it be used?
The Masimo SafetyNet is supplied as a cloud-based telehealth platform that connects to Masimo pulse oximeters and temperature sensors. It is intended for use in both hospital and outpatient settings, providing remote monitoring capabilities beyond traditional clinical environments. The system transmits near-real-time vital signs to a central monitoring station, facilitating continuous oversight of at-risk patients.
Are the SET® sensors used with the Masimo SafetyNet single-use or reusable?
The Masimo SafetyNet system is designed for use with single-use sensors where applicable, though the specific sterility or reuse instructions for all components are not detailed in the provided data. The tetherless SET® sensors are intended to minimize patient discomfort and reduce infection risks, aligning with single-use best practices in clinical monitoring.
Does the Masimo SafetyNet include any size variations or special considerations for patient use?
The provided specifications do not mention any size variations for the Masimo SafetyNet system or its sensors. The device is intended for general use with standard Masimo pulse oximeters and temperature sensors, which are typically designed to accommodate a range of patient sizes. However, compatibility should be confirmed with the manufacturer for specific patient populations or clinical needs.
What regulatory approval does the Masimo SafetyNet hold, and how is it classified?
The Masimo SafetyNet is classified as a Class II medical device under FDA regulation 868.2250, specifically as a Monitor for Opioid-Induced Impairment of Oxygenation. It holds FDA clearance via a 510(k) submission (K200011), indicating it meets regulatory standards for remote patient monitoring and safety in clinical settings. The approval process involved the Anesthesiology Advisory Committee.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Masimo - Masimo SafetyNet Cloud-based Telehealth Platform, Masimo - Home, Masimo - Patient SafetyNet, Masimo - Wikipedia, Masimo - Masimo SafetyNet
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN200011 | Class II | Active |
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Manufacturer
- Manufacturer
- Masimo Corporation
Sources (1)
- FDA 510(k) DEN200011 24 fields · synced Oct 1, 2026