# K101387: Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CN

- Pathway: 510(k) (Traditional)
- Applicant: Fudakang Industries Co., Ltd.
- Decided: Aug 3, 2010 after 77 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: 2 generations back to K010238 (2001). 2 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072641: Digital Electronic Thermometer, Model: FDTH-V0-1 Thru 4., Famidoc Technology Co., Ltd. (2007) Summary page 2.

## Most influential descendants
- K132514: Kinsa Smart Thermometer (2013), 2 descendants of its own
- K203731: DT100 Digital Thermometer (2021), 1 descendant of its own
- K190990: Digital Thermometer (2019), 1 descendant of its own
- K152739: Electronic Thermometer (2016), 1 descendant of its own
- K214077: Digital Thermometer, Model: DT007, DT008 (2023), 0 descendants of its own

## Indications for use
Fudakang Digital Thermometers are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home. BT-Al 1CN, BT-A21CN, BT-A41CN can be used for axillary measurement, oral measurement and rectal measurement.

Source page: https://510kreport.com/device/K101387
Methodology: https://510kreport.com/methodology