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510(k) K021060

FRESENIUS ICARE MONITORING SYSTEM by Fresenius Medical Care North America — Product Code FKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2002
Date Received
April 2, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Single Patient
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K131611 — FRESENIUS DRY ACID DISSOLUTION UNITS (August 29, 2013)
  • K124035 — 2008K@HOME HEMODIALYSIS MACHINE (July 3, 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)

Other clearances for product code FKP

  • K181991 — NxStage Connected Health System (September 26, 2018)
  • K131739 — NXSTAGE CONNECTED HEALTH SYSTEM (October 10, 2013)
  • K130460 — NXSTAGE DOSING CALCULATOR (July 11, 2013)
  • K040074 — ONEVIEW INTERFACE (April 8, 2004)
  • K003615 — STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS (February 1, 2001)
  • K992255 — CKHEMO, MODEL CKHEMO VERSION 1.0 (November 30, 1999)
  • K964264 — HIGH RANGE PEROXIDE TEST STRIP (June 16, 1997)
  • K955423 — PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (June 13, 1996)
  • K953854 — WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE (March 11, 1996)
  • K930181 — BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE (November 29, 1995)