# K222057: Thermoclick

- Pathway: 510(k) (Traditional)
- Applicant: T&R BIOFAB CO., Ltd.
- Decided: Dec 5, 2023 after 511 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: 6 generations back to K000969 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211776: Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT), Microlife Intellectual Property GmbH (2022) Summary page 6.

## Indications for use
The THERMOCLICK is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home. The device can be used in connection with a smart phone running the THERMOCLICK Mobile Application. The memory data can be transferred to the smart phone via Bluetooth.

Source page: https://510kreport.com/device/K222057
Methodology: https://510kreport.com/methodology