Cleared Special

K161933 - The Braun ThermoScan® 3 High Speed Compact Ear Thermometer

K161933 is an FDA 510(k) clearance for The Braun ThermoScan 3 High Speed Compa..., manufactured by Kaz USA, Inc., A Helen of Troy Company. The device is a Class 2 General Hospital device with product code FLL cleared through the Special 510(k) pathway after a 33-day FDA review.

K161933 · Kaz USA, Inc., A Helen of Troy Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
33d
Days
Class 2
Risk

K161933 is an FDA 510(k) clearance for the The Braun ThermoScan® 3 High Speed Compact Ear Thermometer. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Kaz USA, Inc., A Helen of Troy Company (Marlborough, US). The FDA issued a Cleared decision on August 16, 2016 after a review of 33 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Kaz USA, Inc., A Helen of Troy Company devices

FDA 510(k) Submission Details - K161933

510(k) Number K161933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2016
Decision Date August 16, 2016
Days to Decision 33 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 129d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

FLL Device Classification - Class 2, Special Controls

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 646
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K161933.
Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)
K160816 · Nexmed Technology Co., Ltd. · Sep 2016
Digital Thermometer
K161211 · Biocare Asia Corporation , Ltd. · Aug 2016
Infrared Forehead Thermometer, FT-100A
K160802 · Hangzhou Universal Electronic Co., Ltd. · Aug 2016
Infra-red forehead thermometer
K160999 · Hangzhou Hua'An Medical&Health Instruments Co.,Ltd · Aug 2016
ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer
K152905 · Arc Devices Limited · Jul 2016
Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)
K160308 · Fudakang Industrial Co., Ltd. · Jul 2016