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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K252805
Device Name YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
Applicant
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
#1 Baisheng Rd. Development Zone
Danyang,  CN 212300
Applicant Contact Fang (Fawn) Zhang
Correspondent
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
#1 Baisheng Rd. Development Zone
Danyang,  CN 212300
Correspondent Contact Fang (Fawn) Zhang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/03/2025
Decision Date 02/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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