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510(k) K252423

NovaLine Tubing Set for Hemodialysis (BL 124) by Bain Medical Equipment (Guangzhou) Co., Ltd. — Product Code FJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2026
Date Received
August 1, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Bain Medical Equipment (Guangzhou) Co., Ltd.

  • K240164 — NovaLine SP-C35 Transducer Protector (956007) (June 28, 2024)
  • K213015 — DORA Disposable A.V. Fistula Needle Sets (April 8, 2022)
  • K201866 — NovaLine Tubing Sets for Hemodialysis (March 10, 2021)
  • K203524 — Surgical Masks (February 25, 2021)
  • K163025 — DORA Disposable A.V. Fistula Needle Sets (July 20, 2017)
  • K161582 — DORA Tubing Sets for Hemodialysis (June 16, 2017)

Other clearances for product code FJK

  • K251341 — VITAL Tubing Sets for Hemodialysis (January 16, 2026)
  • K251442 — TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) (October 2, 2025)
  • K243607 — Moda-flx Hemodialysis System™ Cartridge (102121-001 ) (December 20, 2024)
  • K213992 — CombiSet Hemodialysis Blood Tubing Set (May 31, 2023)
  • K210782 — Tablo Cartridge (November 26, 2021)
  • K202796 — SANSIN Tubing Sets for Hemodialysis (September 6, 2021)
  • K201866 — NovaLine Tubing Sets for Hemodialysis (March 10, 2021)
  • K171952 — Dimesol Tubing Sets for Hemodialysis (March 30, 2018)
  • K161582 — DORA Tubing Sets for Hemodialysis (June 16, 2017)
  • K150304 — Oxyless Blood Tubing Set (February 24, 2016)