Cleared Traditional

YUWELL infrared ear thermometer: YHT101, YHT200

K203583 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · General Hospital

May 2021

Decision

163d

Days

Class 2

Risk

About This 510(k) Submission

K203583 is an FDA 510(k) clearance for the YUWELL infrared ear thermometer: YHT101, YHT200, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. (Jiangsu, CN). The FDA issued a Cleared decision on May 20, 2021, 163 days after receiving the submission on December 8, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K203583 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 08, 2020
Decision Date	May 20, 2021
Days to Decision	163 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.