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510(k) K002761

FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS by Fresenius Medical Care North America — Product Code FJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2000
Date Received
September 5, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Capillary, Hollow Fiber
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Fresenius Medical Care North America

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  • K152367 — Optiflux dialyzer (October 29, 2015)
  • K123262 — OPTIFLUX ULTRA DIALYZER (January 6, 2014)
  • 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 FJI

  • K190459 — Hemoflow F3 and F4 Dialyzers (August 23, 2019)
  • K122952 — NIPRO PUREFLUX-L HEMODIALYZER (December 4, 2013)
  • K043342 — POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS (May 27, 2005)
  • K010366 — DISPOSABLE STORAGE CAP (November 28, 2001)
  • K011148 — ULTRACONCENTRATOR SYSTEM (June 13, 2001)
  • K991908 — IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS (April 17, 2000)
  • K992594 — A-15 HEMODIALYZER (September 24, 1999)
  • K992565 — A-18 HEMODIALYZER (September 23, 1999)
  • K991512 — ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X (July 29, 1999)
  • K990159 — DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 (April 19, 1999)