# K062445: Monitoring Ear Thermometer, Model BTM-D1A

- Pathway: 510(k) (Traditional)
- Applicant: Rio Flexon Technology Co., Ltd.
- Decided: Feb 16, 2007 after 178 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: 3 generations back to K010462 (2001). 5 ancestors in all.
39 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)
- K050463: Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110 Ear/Skin/Surface IR Thermometer, Taidoc Technology Corporation (2005) Summary page 1.
- K003326: Funet Amy Mama Body Thermometer, Funai Radio & Communications Corp. (2001) Summary page 1.

## Most influential descendants
- K081256: Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and H (2008), 38 descendants of its own
- 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

## Indications for use
The Monitoring Ear Thermometer, model BTM-D1A is the battery-operated electronic devices with intended use of measuring human ear temperature precisely and continuously monitor 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 olds.

Source page: https://510kreport.com/device/K062445
Methodology: https://510kreport.com/methodology