# K152640: Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT)

- Pathway: 510(k) (Special)
- Applicant: Fudakang Industries Co., Ltd.
- Decided: Mar 28, 2016 after 195 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Infrared Thermometer (FT-F11-BT) is intended for an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population. Infrared Thermometers (FT-F21-BT, FT-F31-BT, FT-F41-BT) are intended for intermittent measurement of human body temperature in people of all ages.

Source page: https://510kreport.com/device/K152640
Methodology: https://510kreport.com/methodology