# K181015: Braun BFH175 Infrared Forehead Thermometer

- Pathway: 510(k) (Special)
- Applicant: Kaz USA, Inc., A Helen of Troy Company
- Decided: Jul 18, 2018 after 92 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 K011291 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163516: Braun No Touch + Forehead NTF3000 Thermometer, Kaz USA, Inc., A Helen of Troy Company (2017) Summary page 4.

## Indications for use
The Braun BFH175 Infrared Forehead Thermometer is a non-sterile, reusable, clinical thermometer intended for the intermittent determination of human body temperature in a touch mode using the center of the forehead as the measurement site on people of all ages.

Source page: https://510kreport.com/device/K181015
Methodology: https://510kreport.com/methodology