# K160308: Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)

- Pathway: 510(k) (Special)
- Applicant: Fudakang Industrial Co., Ltd.
- Decided: Jul 15, 2016 after 162 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K172121: Digital Thermometer (2018), 0 descendants of its own

## Indications for use
Fudakang Bluetooth Digital thermometer (Model: BT-A41CN-BT) is intended for the measurement and monitoring of oral, axillary, and rectal temperature of adults via a thermistor. The device is for use of a doctor or lay consumers in the hospital or home. The result of measurement can be transmitted to smart mobile device (cell phone, iPad) while displayed on the LCD.

Source page: https://510kreport.com/device/K160308
Methodology: https://510kreport.com/methodology