# K033082: 9 Second Digital Thermometer, Model BT-S09

- Pathway: 510(k) (Traditional)
- Applicant: Metatech Co., Ltd.
- Decided: Dec 3, 2003 after 65 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 K943695 (1995). 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)
- K031958: Microlife Instant Digital Electronic Thermometer, Model QT1JA1, Microlife Intellectual Property GmbH (2003) Summary page 1.

## Indications for use
This device is an electronic clinical thermometer using a thermistor probe sensor to detect body temperature. The device is measuring oral, rectal or axillary temperatures. It is intended for home use on people of all ages.

Source page: https://510kreport.com/device/K033082
Methodology: https://510kreport.com/methodology