# K240333: Wearable Digital Thermometer (T31)

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Genial Technology Co., Ltd.
- Decided: Oct 30, 2024 after 268 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). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222588: Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1, Iweecare Co., Ltd. (2023) Summary page 6.

## Indications for use
Wearable Digital Thermometer is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. Wearable Digital Thermometer is reusable and intended for armpit temperature monitoring for persons of all age. The temperature data of device is not intended to replace the advice, diagnosis, nor treatment recommendations of doctor. Wearable Digital Thermometer can be used at home and healthcare center.

Source page: https://510kreport.com/device/K240333
Methodology: https://510kreport.com/methodology