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510(k) K121421

FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) by Fresenius Medical Care North America, Design Cente — Product Code ONW

K121421 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care North America, Design Cente for the device "FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)". The FDA issued a decision of Substantially Equivalent on January 17, 2013. The device falls under product code ONW (Hemodialysis System For Home Use), a Class II device regulated under 21 CFR 876.5860. Fresenius Medical Care North America, Design Cente has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2013
Date Received
May 14, 2012
Clearance Type
Special
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, Design Cente

  • K123630 — FRESENIUS LIBERTY CYCLER (September 9, 2013)
  • K120823 — BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTE (June 15, 2012)
  • K120505 — FRESENIUS 2008T HEMODIALYSIS MACHINE (March 6, 2012)
  • K101715 — FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 (December 21, 2010)

Other clearances for product code ONW

  • K242269 — SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube S (November 1, 2024)
  • K124035 — 2008K@HOME HEMODIALYSIS MACHINE (July 3, 2013)
  • K070049 — FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR (February 3, 2011)

FDA data resources