# K223037: Infrared Thermometer, Model: IR8807

- Pathway: 510(k) (Traditional)
- Applicant: Shen Zhen Rong Feng Technology Co., Ltd.
- Decided: Jul 21, 2023 after 295 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 K011291 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173048: No-contact Forehead Thermometer, Dongguan Simzo Electronic Technology Co., Ltd. (2018) Summary page 4.

## Indications for use
The Infrared Thermometer (Model: IR8807) is intended for the intermittent measurement of human body temperature from the forehead. It is a non-contact clinical thermometer and intended for use on people of all ages except for neonates/newborns.

Source page: https://510kreport.com/device/K223037
Methodology: https://510kreport.com/methodology