# K203731: DT100 Digital Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Smart Technology Co., Ltd.
- Decided: Sep 26, 2021 after 279 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.
1 later device descends from it; 1 cites it directly.
0 of 5 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.

## Most influential descendants
- K214077: Digital Thermometer, Model: DT007, DT008 (2023), 0 descendants of its own

## Indications for use
DT100 Digital thermometer is intended for the measurement of human body temperature by doctor or consumers in the hospital or home. It can be used for axillary, oral and rectal measurement. The product is reusable and provided non-sterile. The device is for people of all ages.

Source page: https://510kreport.com/device/K203731
Methodology: https://510kreport.com/methodology