# K201600: Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28

- Pathway: 510(k) (Traditional)
- Applicant: Kangfu Medical Equipment Factory
- Decided: Dec 10, 2021 after 546 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: 5 generations back to K010462 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171214: Infrared Thermometer, Shenzhen Brav Electronic Technologies Co., Ltd. (2018) Summary page 4.

## Indications for use
The infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28 is designed to measuring human body temperature through ear or forehead in the healthcare environments or home use and is non-sterile. The thermometer is a reusable device intended for people of all ages except neonates/newborns.

Source page: https://510kreport.com/device/K201600
Methodology: https://510kreport.com/methodology