# K203215: Radius T wearable thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Jun 11, 2021 after 221 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K010462 (2001). 16 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181013: Fever Scout, VivaLNK, Inc. (2018) Summary page 4.

## Most influential descendants
- K232010: iTEMPSHIELD (2023), 1 descendant of its own
- K250401: AION TempShield™ (2025), 0 descendants of its own

## Indications for use
Radius T wearable thermometer is intended for single-use, continuous noninvasive measurement of body temperature on the upper chest via wireless communication to a smart device application or compatible patient monitor (i.e., Masimo Root, Masimo Rad-97). The Radius T is indicated for single-use, continuous body temperature measurements of persons 5 years of age or older in hospitals, hospital-type facilities, and home environments.

Source page: https://510kreport.com/device/K203215
Methodology: https://510kreport.com/methodology