# K202791: iHealth Clinical Digital Thermometer

- Pathway: 510(k) (Abbreviated)
- Applicant: Andon Health Co, Ltd.
- Decided: Jan 5, 2021 after 105 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: 10 generations back to K010462 (2001). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180131: Vicks RapidRead Digital Thermometer, Kaz USA, Inc., A Helen of Troy Company (2018) Summary page 4.

## Most influential descendants
- K211352: Electronic Thermometer (XHF2001, XHF2002) (2021), 0 descendants of its own

## Indications for use
The Clinical Digital Thermometer is intended to measure the body temperature oral or axillaries (under the arm) and to be used by consumers in household environments. It is intended for use on adults and children ages 4 and up.

Source page: https://510kreport.com/device/K202791
Methodology: https://510kreport.com/methodology