Cleared Traditional

Radius T wearable thermometer

K203215 · Masimo Corporation · General Hospital

Jun 2021

Decision

221d

Days

Class 2

Risk

About This 510(k) Submission

K203215 is an FDA 510(k) clearance for the Radius T wearable thermometer, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on June 11, 2021, 221 days after receiving the submission on November 2, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K203215 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 2020
Decision Date	June 11, 2021
Days to Decision	221 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FLL — Continuous Measurement Thermometer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.2910
Definition	A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.