Cleared Special

Braun BNT400 No Touch + Forehead Thermometer

K181242 · Kaz USA, Inc., A Helen of Troy Company · General Hospital

Jul 2018

Decision

74d

Days

Class 2

Risk

About This 510(k) Submission

K181242 is an FDA 510(k) clearance for the Braun BNT400 No Touch + Forehead Thermometer, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Kaz USA, Inc., A Helen of Troy Company (Marlborough, US). The FDA issued a Cleared decision on July 23, 2018, 74 days after receiving the submission on May 10, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K181242 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 10, 2018
Decision Date	July 23, 2018
Days to Decision	74 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FLL — Continuous Measurement Thermometer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.2910
Definition	A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.