Modification To Masimo Set Radical Pulse Oximeter With Satshare And Lnop Series…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K002939 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 with SatShare is a pulse oximeter designed for continuous non-invasive monitoring of arterial hemoglobin oxygen saturation (SpO₂) and pulse rate. It incorporates the Masimo SET technology, which enhances signal quality and reliability in diverse patient populations, including adults, pediatric, and neonatal patients. The device integrates with existing multiparameter monitors via the SatShare interface, enabling seamless data transmission without requiring additional computer interfaces. Its LNOP series sensors are optimized for consistent performance across varying clinical settings.
This pulse oximeter is supplied as a reusable medical device, intended for use in hospitals, hospital-type facilities, mobile care environments, and home settings. It operates in accordance with FDA 510(k) clearance (K002939) under the Special review pathway, with no third-party involvement. The SatShare interface connects directly to the host monitor’s oximeter input, ensuring compatibility with validated multiparameter systems. Storage and handling follow standard medical device protocols to maintain functionality and sterility where applicable, though specific sterility claims are not provided in the data.
Frequently asked questions
What is the Masimo SET Radical Pulse Oximeter with SatShare used for?
This device is designed for continuous, non-invasive monitoring of arterial hemoglobin oxygen saturation (SpO₂) and pulse rate. The Masimo SET technology improves signal quality and reliability across diverse patient populations, including adults, pediatric, and neonatal patients, making it suitable for use in hospitals, mobile care environments, and home settings.
How is the Masimo SET Radical Pulse Oximeter with SatShare supplied and intended for reuse?
The device is supplied as a reusable medical device. It is intended for repeated use in clinical settings, provided proper cleaning, maintenance, and storage protocols are followed to ensure functionality and hygiene. Reusability aligns with its design for long-term use in hospitals, hospital-type facilities, and other healthcare environments.
What are the LNOP series sensors, and how do they enhance performance?
The LNOP series sensors are optimized for consistent performance across varying clinical settings. They are part of the Masimo SET Radical Pulse Oximeter system and are designed to improve signal quality and reliability, ensuring accurate SpO₂ and pulse rate readings in different patient populations and environments.
How does the SatShare interface work with existing monitors?
The SatShare interface enables seamless data transmission from the Masimo SET Radical Pulse Oximeter to existing multiparameter monitors. It connects directly to the host monitor’s oximeter input, eliminating the need for additional computer interfaces and ensuring compatibility with validated systems.
What storage and handling guidelines should be followed for this device?
Storage and handling should adhere to standard medical device protocols to maintain functionality. While specific sterility claims are not provided, proper cleaning, maintenance, and storage practices are essential to preserve the device’s performance and ensure safe reuse in clinical settings.
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, Modification to Masimo Set Radical Pulse Oximeter With Satshare and ..., Modification to Masimo Set Radical Pulse Oximeter With Satshare and ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K002939 | Class II | Active |
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Manufacturer
- Manufacturer
- Masimo Corporation
- FDA Applicant
- Masimo Corp.
Sources (1)
- FDA 510(k) K002939 24 fields · synced Oct 1, 2026