# K100226: Wireless Body Temperature Monitor Model BTM-Dix Series (BTM-Dic,D,E,F,G & H)

- Pathway: 510(k) (Special)
- Applicant: Rio Flexon Technology Co., Ltd.
- Decided: Mar 18, 2010 after 52 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: 5 generations back to K010462 (2001). 7 ancestors in all.
37 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)
- K081256: Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and H, Rio Flexon Technology Co., Ltd. (2008) Summary page 2.

## Most influential descendants
- 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
- K191272: Wearable Device, Wearable Package (2019), 16 descendants of its own

## Indications for use
The Wireless Body Temperature Monitor, model BIM-DIX series (model BTM-D1IC, D, E, F, O and H), is a battery-operated electronic device with intended use of measuring human ear temperature precisely and continuously monitoring armpit temperature via wireless signal transmission of the measuring result. This device is reusable and is intended for ear temperature measurement as well as armpit temperature monitoring for persons over two years old. Model BTM-D1C has two functions, both ear temperature measurement and armpit temperature monitoring. The rest of models, BTM-D1D, E, F, U and H, have only the function of armpit temperature monitoring.

Source page: https://510kreport.com/device/K100226
Methodology: https://510kreport.com/methodology