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510(k) K124035

2008K@HOME HEMODIALYSIS MACHINE by Fresenius Medical Care North America — Product Code ONW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2013
Date Received
December 28, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemodialysis System For Home Use
Device Class
Class II
Regulation Number
876.5860
Review Panel
GU
Submission Type

To treat and provide hemodialysis therapy at home for chronic renal failure patients.

Other clearances by Fresenius Medical Care North America

  • K252181 — AquaA (September 9, 2025)
  • K162488 — Optiflux dialyzer (April 6, 2017)
  • K152953 — CRIT-LINE CLIP (CLIC) BLOOD CHAMBER (November 5, 2015)
  • K152367 — Optiflux dialyzer (October 29, 2015)
  • K123262 — OPTIFLUX ULTRA DIALYZER (January 6, 2014)
  • K131611 — FRESENIUS DRY ACID DISSOLUTION UNITS (August 29, 2013)
  • K121341 — FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM (December 6, 2012)
  • K120017 — FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM (February 2, 2012)
  • K113427 — FRESENIUS 2008T HEMODIALYSIS MACHINE (December 21, 2011)
  • K070049 — FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR (February 3, 2011)

Other clearances for product code ONW

  • K242269 — SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube S (November 1, 2024)
  • K121421 — FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALE (January 17, 2013)
  • K070049 — FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR (February 3, 2011)