Masimo Set Radical Pulse Oximeter With Satshare, Masimo Lnop -adt-Adult/Pediatr…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K992340 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 Radical Pulse Oximeter with SatShare is a pulse oximetry device designed for non-invasive monitoring of blood oxygen saturation (SpO₂) and pulse rate. It employs Masimo SET® technology to provide reliable measurements even in challenging conditions, such as motion or low perfusion. The device integrates with existing multiparameter monitors via the SatShare interface, enabling seamless upgrade of conventional pulse oximetry systems. Its disposable sensors (LNOP-ADT for adults/pediatrics and LNOP-PDT for pediatric use) are engineered for single-use applications, ensuring patient safety and hygiene.
This device is supplied as a standalone pulse oximeter with disposable sensors and a SatShare cable for interfacing with compatible monitors. It is intended for use in clinical settings, including hospitals, intensive care units, and transport environments. The sensors are non-sterile and intended for single-use only, adhering to standard infection control protocols. The device carries FDA 510(k) clearance (K992340) under the Cardiovascular advisory committee, confirming its regulatory compliance for pulse oximetry applications. Storage and handling follow standard medical device guidelines to maintain performance and sterility.
Frequently asked questions
What clinical scenarios is the Radical Pulse Oximeter with SatShare best suited for, and how does it improve reliability in those settings?
The Radical Pulse Oximeter with SatShare is ideal for dynamic or challenging environments like intensive care units, patient transport, or emergency rooms where motion or low perfusion can interfere with accurate readings. Its Masimo SET® technology enhances reliability by delivering stable measurements even under these conditions, ensuring consistent blood oxygen saturation (SpO₂) and pulse rate monitoring.
Are the disposable sensors reusable, and if not, what hygiene protocols should be followed when using them?
No, the disposable sensors (LNOP-ADT for adults/pediatrics and LNOP-PDT for pediatric use) are designed for single-use only to maintain patient safety and hygiene. Each sensor must be discarded after one use, and standard infection control protocols—such as hand hygiene and proper disposal—should be followed to prevent cross-contamination.
How does the SatShare interface benefit clinicians who already use multiparameter monitors in their facility?
The SatShare interface allows the Radical Pulse Oximeter to integrate seamlessly with existing multiparameter monitors, enabling clinicians to upgrade their pulse oximetry systems without replacing their current infrastructure. This compatibility ensures continuity of care while leveraging the device’s advanced SET® technology for more reliable SpO₂ and pulse rate readings.
What storage conditions are recommended to maintain the performance and integrity of the Radical Pulse Oximeter and its disposable sensors?
The device and sensors should be stored according to standard medical device guidelines, which typically include protecting them from extreme temperatures, moisture, and physical damage. The disposable sensors are non-sterile and should be kept in their original packaging until use to preserve functionality and sterility. Always follow manufacturer instructions for optimal storage.
What regulatory pathway was followed for FDA clearance, and what does this mean for clinicians using the device?
The Radical Pulse Oximeter received FDA 510(k) clearance (K992340) under the Cardiovascular advisory committee, confirming it is deemed *substantially equivalent* to a legally marketed predicate device. This means it meets FDA standards for safety and effectiveness as a pulse oximetry system, allowing clinicians to rely on its performance for non-invasive monitoring of SpO₂ and pulse rate 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, Masimo - Radical-7, Masimo - Wikipedia, PDF LAB3474C - masimo.co.jp, MASIMO RADICAL OPERATOR'S MANUAL Pdf Download
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K992340 | Class II | Active |
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Manufacturer
- Manufacturer
- Masimo Corporation
- FDA Applicant
- Masimo Corp.
Sources (1)
- FDA 510(k) K992340 24 fields · synced Sep 20, 2026