# K202481: ThermArt (Model IR-EFT)

- Pathway: 510(k) (Traditional)
- Applicant: Comper Chuangxiang (Beijing) Technology Co., Ltd.
- Decided: Sep 28, 2021 after 396 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: 8 generations back to K011059 (2001). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190873: Infrared Ear/Forehead Thermometer, Joytech Healthcare Co., Ltd. (2019) Summary page 4.

## Indications for use
This device is a non-sterile reusable, contact thermometer, intended for intermittent determination of human body temperature through on the ear canal or forehead as the measurement site on people of all age. The ThermArt (Model IR-EFT) can be used in clinical and home environment.

Source page: https://510kreport.com/device/K202481
Methodology: https://510kreport.com/methodology