# K081256: Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and H

- Pathway: 510(k) (Traditional)
- Applicant: Rio Flexon Technology Co., Ltd.
- Decided: May 27, 2008 after 25 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 K010462 (2001). 6 ancestors in all.
38 later devices descend from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062445: Monitoring Ear Thermometer, Model BTM-D1A, Rio Flexon Technology Co., Ltd. (2007) Summary page 2.

## Most influential descendants
- K100226: Wireless Body Temperature Monitor Model BTM-Dix Series (BTM-Dic,D,E,F,G & H) (2010), 37 descendants of its own
- K121696: Wireless Thermometer (2012), 36 descendants of its own
- K132761: Wireless Thermometer (2014), 35 descendants of its own
- K160306: Cloud Smart Thermometer (2016), 27 descendants of its own
- K181013: Fever Scout (2018), 26 descendants of its own

## Indications for use
The Wireless Body temperature monitor, model BTM-D lx series (model BTM-D 1C, D, E, F, G and H) is the battery-operated electronic devices with intended use of measuring human ear temperature precisely and continuously monitors armpit temperature via wireless signal transmission of measuring result. This device is reusable and intended for ear temperature measurement as well as the armpit temperature monitor for the person above two years old. In which, model BTM-DIC is with two functions of ear temperature measurement and armpit temperature monitor; the rest of models, BTM-D 1D, E, F, G and H are only with the function of armpit temperature monitor.

Source page: https://510kreport.com/device/K081256
Methodology: https://510kreport.com/methodology