Cleared Traditional

K201864 - YUWELL Infrared Thermometer

K201864 is an FDA 510(k) clearance for YUWELL Infrared Thermometer, manufactured by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K201864 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · General Hospital
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Dec 2020
Decision
154d
Days
Class 2
Risk

K201864 is an FDA 510(k) clearance for the YUWELL Infrared Thermometer. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. (Danyang, CN). The FDA issued a Cleared decision on December 7, 2020 after a review of 154 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 Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. devices

FDA 510(k) Submission Details - K201864

510(k) Number K201864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2020
Decision Date December 07, 2020
Days to Decision 154 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
25d slower than avg
Panel avg: 129d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 361
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K201864.
Fever Garde
K191978 · Hubdic Co., Ltd. · Dec 2020
Infrared Thermometer
K201980 · Contec Medical Systems Co.,Ltd · Dec 2020
Infrared Body Thermometer
K200781 · Heitaida Technology Co., Ltd. · Dec 2020
TempTraq
K201977 · Blue Spark Technologies, Inc. · Dec 2020
Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)
K193621 · Dongguan E-Test Technology Co., Ltd. · Nov 2020
Infrared ear and forehead thermometer, model YI-100
K201843 · Wenzhou Yosun Medical Technology Co.,Ltd · Oct 2020