Masimo Set Radical Pulse Oximeter With Satshare And LNOP Series Of Sensors And Cables
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K003167 FDA 510(k)
- FDA Product Code
- DQA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Masimo Set Radical Pulse Oximeter is a medical device designed to monitor oxygen saturation and pulse rate. It utilizes SatShare technology to interface with multiparameter monitors, replacing conventional pulse oximetry with Masimo SET technology.
This device connects to host monitor oximeter input connectors using LNOP series sensors and cables. It is authorized via FDA 510k clearance and is intended for use with validated patient monitors.
Frequently asked questions
What is the primary function of the Masimo SET Radical Pulse Oximeter?
This device is designed to monitor a patient's pulse rate and oxygen saturation levels. It is specifically engineered to integrate with existing multiparameter monitors using SatShare technology, allowing facilities to upgrade to Masimo SET technology while utilizing their current host monitor infrastructure.
Which sensors and cables are compatible with this device?
The Masimo SET Radical Pulse Oximeter is designed to connect to host monitor oximeter input connectors exclusively using the LNOP series of sensors and cables. Using the correct series ensures proper signal acquisition and compatibility with the device's monitoring technology.
How does the SatShare technology work with other monitors?
SatShare technology allows the Radical Pulse Oximeter to interface directly with the oximetry input connectors of validated multiparameter patient monitors. This process replaces conventional pulse oximetry signals with the Masimo SET signal, providing the performance benefits of Masimo technology through the existing display and alarm systems of the host monitor.
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 - SatShare Cable, Masimo - LNC Patient Cables, Masimo - Wikipedia, PDF LAB3474C - masimo.co.jp
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K003167 | Class II | Active |
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Manufacturer
- Manufacturer
- Masimo Corporation
- FDA Applicant
- Masimo Corp.
Sources (1)
- FDA 510(k) K003167 24 fields · synced Sep 25, 2026