Cleared Special

K163516 - Braun No Touch + Forehead NTF3000 Therm...

K163516 is an FDA 510(k) clearance for Braun No Touch + Forehead NTF3000 Therm..., 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 127-day FDA review.

K163516 · Kaz USA, Inc., A Helen of Troy Company · General Hospital
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Apr 2017
Decision
127d
Days
Class 2
Risk

K163516 is an FDA 510(k) clearance for the Braun No Touch + Forehead NTF3000 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 April 21, 2017 after a review of 127 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K163516

510(k) Number K163516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2016
Decision Date April 21, 2017
Days to Decision 127 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 129d · This submission: 127d
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 375
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K163516.
Digital Thermometer
K170262 · K-Jump Health Co., Ltd. · Sep 2017
Digital Thermometer
K163518 · Joytech Healthcare Co. , Ltd. · Sep 2017
Microlife Digital Infrared Ear Thermometer
K170219 · Microlife Intellectual Property GmbH · Jul 2017
Non-contact Forehead Thermometer
K161735 · Shenzhen Dongdixin Technology Co., Ltd. · Nov 2016
Temperature Probe, Affinity Temperature Probe
K160091 · Medtronic, Inc. · May 2016
TD-1035 Thermometer
K152680 · Taidoc Technology Corporation · May 2016