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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(k) Number K251442
Device Name TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)
Applicant
Ningbo Tianyi Medical Appliance Co., Ltd.
#788, Mozhi N. Rd., Tourism Resort, Dongqian Lake
Ningbo,  CN 315121
Applicant Contact Wenyu Zhang
Correspondent
Suzhou Device Innovation Medical Consulting Co., Ltd.
Rm. 1001, Bldg. 19, # 3188 Renming Rd.
Suzhou,  CN 215031
Correspondent Contact Mike Gu
Regulation Number876.5820
Classification Product Code
FJK  
Date Received05/09/2025
Decision Date 10/02/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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