# K201980: Infrared Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Contec Medical Systems Co.,Ltd
- Decided: Dec 18, 2020 after 155 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: 6 generations back to K011291 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182597: Infrared thermometer, Shenzhen Pango Electronic Co., Ltd. (2019) Summary page 6.

## Indications for use
The TP500 Infrared Thermometer is intended to measure human body temperature by measuring from 1-3cm distance to the forehead. The device can be used on people of all ages. It is recommended that the device be operated by an adult. The device is intended to be used in the hospital and other clinical environments.

Source page: https://510kreport.com/device/K201980
Methodology: https://510kreport.com/methodology