# K200531: iHealth Infrared No-Touch Forehead Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Andon Health Co, Ltd.
- Decided: Jul 15, 2020 after 135 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: 7 generations back to K011059 (2001). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191570: Infrared Thermometer Model MD-H30, Guangzhou Berrcom Medical Device Co., Ltd. (2019) Summary page 4.

## Most influential descendants
- K202753: iHealth Wireless No-Touch Forehead Thermometer (2021), 0 descendants of its own

## Indications for use
The Infrared No-Touch Forehead Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by healthcare providers.

Source page: https://510kreport.com/device/K200531
Methodology: https://510kreport.com/methodology