Home / 510(k) Clearances / K120823

510(k) K120823

BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS by Fresenius Medical Care North America, Design Cente — Product Code FJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2012
Date Received
March 19, 2012
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 Fresenius Medical Care North America, Design Cente

  • K123630 — FRESENIUS LIBERTY CYCLER (September 9, 2013)
  • K121421 — FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALE (January 17, 2013)
  • K120505 — FRESENIUS 2008T HEMODIALYSIS MACHINE (March 6, 2012)
  • K101715 — FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 (December 21, 2010)

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)