# K172121: Digital Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Fudakang Industrial Co., Ltd.
- Decided: Jun 7, 2018 after 329 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: 5 generations back to K010238 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160308: Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT), Fudakang Industrial Co., Ltd. (2016) Summary page 4.
- K152739: Electronic Thermometer, Guangdong Biolight Meditech Co., Ltd. (2016) Summary page 4.

## Indications for use
Digital thermometers (Model: TP-100, TP-200, TP-300, TP-400, TP-500, BT-A31A-BT) is intended for the measurement and monitoring of oral or axillary for adult , pediatric and infant temperature via thermistor by doctor or consumers in the hospital or home. The result of measurement and monitoring will be transmitted via Bluetooth (BLE) to Bluetooth enabled smart mobile device (cell phone, iPad) with GuardiAngel App installed.

Source page: https://510kreport.com/device/K172121
Methodology: https://510kreport.com/methodology