# K140681: Belter Infra-Red Ear Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Belter Health Measurement and Analysis TE
- Decided: Aug 21, 2014 after 156 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 K111637 (2011). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111637: Infrared Ear Thermometer, Radiant Innovation, Inc. (2011) Summary page 4.

## Most influential descendants
- K180314: Infrared Thermometer (2018), 0 descendants of its own

## Indications for use
The Belter Infra-red Ear thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages for home and professional use.

Source page: https://510kreport.com/device/K140681
Methodology: https://510kreport.com/methodology