# K214077: Digital Thermometer, Model: DT007, DT008

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Berrcom Medical Device Co., Ltd.
- Decided: Jan 20, 2023 after 389 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: 4 generations back to K010238 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203731: DT100 Digital Thermometer, Smart Technology Co., Ltd. (2021) Summary page 4.

## Indications for use
DT007 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the hospital. The rectal body temperature measurement cannot be used for multi-patient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages. DT008 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the hospital. The rectal body temperature measurement cannot be used for multi-patient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.

Source page: https://510kreport.com/device/K214077
Methodology: https://510kreport.com/methodology