# K211352: Electronic Thermometer (XHF2001, XHF2002)

- Pathway: 510(k) (Traditional)
- Applicant: Putian Hanjiang Huafeng Plastic Co., Ltd.
- Decided: Sep 9, 2021 after 129 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: 11 generations back to K010462 (2001). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202791: iHealth Clinical Digital Thermometer, Andon Health Co, Ltd. (2021) Summary page 4.

## Indications for use
The Electronic Thermometer (XHF2001, XHF2002) is intended to measure the body temperature under the arm and to be used by consumers in household environments for the people of one month of age and above.

Source page: https://510kreport.com/device/K211352
Methodology: https://510kreport.com/methodology