Cleared Traditional

YUWELL? Infrared Ear Thermometer (YHT100); YUWELL? Infrared Ear Thermometer (YHT107)

K250878 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · General Hospital

May 2025

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K250878 is an FDA 510(k) clearance for the YUWELL? Infrared Ear Thermometer (YHT100); YUWELL? Infrared Ear Thermometer (YHT107), 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 May 22, 2025, 59 days after receiving the submission on March 24, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K250878 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 24, 2025
Decision Date	May 22, 2025
Days to Decision	59 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.