# K240109: Medical electronic thermometer (FC01, FC02)

- Pathway: 510(k) (Traditional)
- Applicant: Zhuzhou Goldenhot Medical Technology Co., Ltd.
- Decided: Apr 12, 2024 after 87 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 K902624 (1990). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223044: Digital Thermometer (Model QT001), Shen Zhen Rong Feng Technology Co., Ltd. (2023) Summary page 4.

## Indications for use
The Medical Electronic Thermometer (FC01, FC02) is intended to measure the human body temperature under the arm. The devices are reusable for clinical or home use for people of all ages.

Source page: https://510kreport.com/device/K240109
Methodology: https://510kreport.com/methodology