Cleared Traditional

YUWELL Infrared Thermometer

K201864 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · General Hospital

Dec 2020

Decision

154d

Days

Class 2

Risk

About This 510(k) Submission

K201864 is an FDA 510(k) clearance for the YUWELL Infrared Thermometer, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. (Danyang, CN). The FDA issued a Cleared decision on December 7, 2020, 154 days after receiving the submission on July 6, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K201864 FDA.gov
FDA Decision	Cleared 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

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.