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Radius T Wearable Thermometer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K203215

by Masimo Corporation

Identifiers

510(k) Number
K203215 FDA 510(k)
FDA Product Code
FLL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.2910 FDA 510(k)
Regulation Number
880.2910 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Radius T Wearable Thermometer is a wireless, non-invasive device classified as a thermometer (FDA Product Code: FLL). It continuously monitors body temperature in adult and pediatric patients, providing real-time data for clinical assessment without direct patient contact.

This single-use, disposable sensor attaches to the skin and transmits temperature readings wirelessly via Bluetooth to compatible devices, such as the Masimo SafetyNet App. Intended for use in general hospital settings, it requires no sterilization and is designed for one-time use per patient. The device holds FDA 510(k) clearance (K203215) and is intended for continuous temperature monitoring as part of patient care protocols.

Frequently asked questions

How does the Radius T wearable thermometer differ from traditional thermometers in terms of usage and convenience for clinicians?

The Radius T is designed for continuous, non-invasive temperature monitoring without direct patient contact, eliminating the need for repeated manual readings. Its single-use, disposable sensor attaches to the skin and wirelessly transmits real-time data via Bluetooth to the Masimo SafetyNet App, allowing clinicians to track trends over time. This reduces handling of the patient and minimizes the risk of cross-contamination compared to traditional thermometers, which often require physical insertion or contact with the patient’s body.

Is the Radius T wearable thermometer reusable, or is it intended for single-use only? How does this affect its clinical workflow?

The Radius T is explicitly designed for single-use only per patient, as stated in the device description. This eliminates the need for sterilization between uses, simplifying workflows in hospital settings where time and infection control are critical. Clinicians can attach a new sensor to each patient without cleaning or reprocessing, ensuring hygiene and reducing potential errors from reuse.

What types of patients can use the Radius T wearable thermometer, and how is it attached to the body?

The Radius T is approved for use in both adult and pediatric patients, making it versatile for a wide range of clinical settings. The disposable sensor is designed to be attached directly to the skin, typically in areas like the forehead or chest, where it adheres securely for continuous monitoring. The wireless transmission via Bluetooth allows readings to be captured remotely without interrupting patient care.

How does the Radius T wearable thermometer integrate with existing hospital systems or monitoring protocols?

The device syncs wirelessly with the Masimo SafetyNet App, enabling real-time temperature data to be viewed on compatible devices. This integration supports clinical assessment by providing continuous trends rather than isolated readings, which can be particularly useful in protocols requiring frequent or prolonged temperature monitoring—such as post-operative recovery or infection surveillance. The app’s connectivity streamlines data collection without requiring additional hardware.

What storage or handling precautions should be taken for the Radius T wearable thermometer sensors before use?

Since the Radius T sensors are single-use and disposable, they should be stored in their original packaging until ready for use to maintain sterility and functionality. The packaging likely includes protective barriers to prevent contamination. Clinicians should avoid exposing the sensors to extreme temperatures, moisture, or physical damage prior to attachment, as this could compromise accuracy or adhesion. Always follow manufacturer guidelines for opening and applying the sensor to ensure proper performance.

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 - Radius T®, Masimo - Radius T° - Getting Started, Radius T° Adult/Pediatric Continuous Body Temperature Sensor - Masimo, Masimo Radius T Wearable Thermometer User Manual

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Masimo Corporation

Sources (1)

  • FDA 510(k) K203215 24 fields · synced Sep 19, 2026