# K163603: Digital Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Jinxinbao Electronic Co., Ltd.
- Decided: Jun 6, 2017 after 167 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: 3 generations back to K010238 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101387: Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CN, Fudakang Industries Co., Ltd. (2010) Summary page 5.

## Indications for use
Digital Thermometer is intended to measure the body temperature either oral or axillaries (under arms) and to be used by consumers in a household environment. The device is intended for repeatable use by one patient. It is intended for use on people of all ages.

Source page: https://510kreport.com/device/K163603
Methodology: https://510kreport.com/methodology