Cleared Traditional

Vicks VNT200 No Touch Forehead Thermometer (K193213) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K193213 · Kaz USA, Inc., A Helen of Troy Company · General Hospital
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Apr 2020
Decision
159d
Days
Class 2
Risk

K193213 is an FDA 510(k) clearance for the Vicks VNT200 No Touch Forehead 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 28, 2020 after a review of 159 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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

Submission Details

510(k) Number K193213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2019
Decision Date April 28, 2020
Days to Decision 159 days
Submission Type Traditional
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
30d slower than avg
Panel avg: 129d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 215
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K193213.
Digital Thermometer
K200599 · Joytech Healthcare Co. , Ltd. · Jul 2020
Infrared Thermometer Model Number RN-60A,RN-60B
K200471 · Ningbo Ranor Medical Science & Technology Co., Ltd. · Jun 2020
Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503
K193253 · Shenzhen Changkun Technology Co., Ltd. · Jun 2020
Infrared Forehead Thermometer
K190984 · Xiamen Ants Bro Technology Co., Ltd. · Apr 2020
Microlife Non-Contact Infrared Forehead Thermometer
K191829 · Microlife Intellectual Property GmbH · Feb 2020
Digital Thermometer
K190990 · Xiamen Ants Bro Technology Co., Ltd. · Dec 2019