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510(k) K955762

PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM by Fresenius USA, Inc. — Product Code KPF

K955762 is an FDA 510(k) premarket notification submitted by Fresenius USA, Inc. for the device "PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM". The FDA issued a decision of Substantially Equivalent on July 31, 1996. The device falls under product code KPF (System, Dialysate Delivery, Semi-Automatic, Peritoneal), a Class II device regulated under 21 CFR 876.5630. Fresenius USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1996
Date Received
December 18, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Semi-Automatic, Peritoneal
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Fresenius USA, Inc.

  • K992275 — FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VO (August 4, 1999)
  • K970700 — FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX (September 15, 1998)
  • K974584 — FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F80 (May 14, 1998)
  • K973378 — C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SE (November 3, 1997)
  • K961465 — 2008H ON LINE CLEARANCE MONITOR (July 3, 1997)
  • K961706 — P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL (July 31, 1996)
  • K941460 — FRESENIUS BLOOD TEMPERATURE MONITOR (July 3, 1996)
  • K955423 — PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (June 13, 1996)
  • K930181 — BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE (November 29, 1995)
  • K944767 — DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER (November 29, 1995)

Other clearances for product code KPF

  • K061515 — RENALSOFT (September 11, 2006)
  • K990953 — RENAL LINK (June 18, 1999)
  • K970989 — CYBERREN (July 24, 1997)
  • K913515 — TOTAL CONTAINMENT DEVICE (May 26, 1994)
  • K875121 — AMICON EQUALINE FLUID BALANCE SYSTEM (February 19, 1988)
  • K874020 — ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE (January 29, 1988)
  • K821328 — C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP (July 28, 1982)
  • K802831 — GAMBRO PERITONEAL DIALYSIS MONITOR (December 18, 1980)
  • K800496 — CYCLER W/5 OR 10 HR. FILL/DWELL TIMER (July 21, 1980)
  • K791676 — PERITONEAL DIALYSIS CYCLER MODEL PDC1000 (December 6, 1979)

FDA data resources