# K193621: Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan E-Test Technology Co., Ltd.
- Decided: Nov 23, 2020 after 333 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: 1 generation back to K172508 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172508: Ageless Health Medical Digital Thermometer, Ageless Health Industrial Co., Ltd. (2018) Summary page 5.

## Indications for use
Digital Thermometers are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home. It can be used for axillary measurement, oral measurement and rectal measurement.

Source page: https://510kreport.com/device/K193621
Methodology: https://510kreport.com/methodology