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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 K252423
Device Name NovaLine Tubing Set for Hemodialysis (BL 124)
Applicant
Bain Medical Equipment (Guangzhou) Co., Ltd.
#10, Juncheng Rd., Eastern Area,
Economic And Technological Development
Guangzhou,  CN 510760
Applicant Contact Zoe Zeng
Correspondent
Bain Medical Equipment (Guangzhou) Co., Ltd.
#10, Juncheng Rd., Eastern Area,
Economic And Technological Development
Guangzhou,  CN 510760
Correspondent Contact Zoe Zeng
Regulation Number876.5820
Classification Product Code
FJK  
Date Received08/01/2025
Decision Date 05/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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