Cleared Traditional

K203215 - Radius T wearable thermometer

K203215 is an FDA 510(k) clearance for Radius T wearable thermometer, manufactured by Masimo Corporation. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K203215 · Masimo Corporation · General Hospital
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Jun 2021
Decision
221d
Days
Class 2
Risk

K203215 is an FDA 510(k) clearance for the Radius T wearable thermometer. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on June 11, 2021 after a review of 221 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Masimo Corporation devices

FDA 510(k) Submission Details - K203215

510(k) Number K203215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 129d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLL Device Classification - Class 2, Special Controls

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 527
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K203215.
Temp Pal
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Infrared Thermometer
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Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)
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YUWELL infrared ear thermometer: YHT101, YHT200
K203583 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · May 2021
Infrared Thermometer
K203454 · Shandong Zhushi Pharmaceutical Group Co., Ltd. · Apr 2021