Braun BNT400 No Touch + Forehead Thermometer
by Kaz USA, Inc., A Helen of Troy Company 510(k)
Active
510(k) K181242
Overview
The Braun BNT400 No Touch + Forehead Thermometer is a clinical thermometer intended for the intermittent determination of human body temperature. It uses dual technology to measure temperature either by placing the device on the forehead or by holding it in front of the forehead in no-touch mode.
The device is non-sterile and reusable. It is supplied for use in general hospital and home settings. Authorization is based on FDA 510(k) clearance under product code FLL, with K-number K181242.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK181242 | Date23 Jul 2018 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 24 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FLL
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
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Questions
What is the Braun BNT400 No Touch + Forehead Thermometer used for?
It is intended for the intermittent determination of human body temperature in clinical and home settings. The device uses dual technology to measure temperature either by placing it on the forehead or holding it in front of the forehead in no-touch mode, making it suitable for quick, non-invasive temperature checks.
Is the Braun BNT400 thermometer sterile or single-use?
The device is non-sterile and designed for reuse. It is not supplied in a sterile condition and should be cleaned according to the manufacturer’s instructions between uses to maintain hygiene and functionality in both hospital and home environments.
How is the Braun BNT400 supplied and where is it intended for use?
The thermometer is supplied for use in general hospital and home settings. It is intended for intermittent temperature measurement and is designed for repeated use after proper cleaning, supporting both clinical and personal health monitoring needs.
What regulatory clearance does the Braun BNT400 have?
The device has FDA 510(k) clearance under product code FLL, with K-number K181242. It was determined to be substantially equivalent to a legally marketed device, based on the submission reviewed and cleared on July 23, 2018.