# K202603: Temp Pal

- Pathway: 510(k) (Traditional)
- Applicant: Iweecare Co., Ltd.
- Decided: Jul 22, 2021 after 317 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: 8 generations back to K010462 (2001). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132761: Wireless Thermometer, Raiing Medical Company (2014) Summary page 4.

## Most influential descendants
- K222588: Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 (2023), 1 descendant of its own
- K240333: Wearable Digital Thermometer (T31) (2024), 0 descendants of its own

## Indications for use
The Temp Pal 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. This system is reusable and intended for armpit temperature monitoring for persons over two years old. The device is for home healthcare used by the layperson.

Source page: https://510kreport.com/device/K202603
Methodology: https://510kreport.com/methodology