# K202753: iHealth Wireless No-Touch Forehead Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Andon Health Co, Ltd.
- Decided: Mar 8, 2021 after 168 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)
- K200531: iHealth Infrared No-Touch Forehead Thermometer, Andon Health Co, Ltd. (2020) Summary page 4.

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

Source page: https://510kreport.com/device/K202753
Methodology: https://510kreport.com/methodology