# K161933: The Braun ThermoScan® 3 High Speed Compact Ear Thermometer

- Pathway: 510(k) (Special)
- Applicant: Kaz USA, Inc., A Helen of Troy Company
- Decided: Aug 16, 2016 after 33 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: 3 generations back to K010462 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052849: Infrared Thermometer, Fdir-V1, Famidoc Technology Co., Ltd. (2005) Summary page 4.

## Indications for use
The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is intended for the intermittent measurement and monitoring of human body temperature by consumers in the home.

Source page: https://510kreport.com/device/K161933
Methodology: https://510kreport.com/methodology