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510(k) K910215

DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST by Cd Medical, Inc. — Product Code FKP

K910215 is an FDA 510(k) premarket notification submitted by Cd Medical, Inc. for the device "DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST". The FDA issued a decision of Substantially Equivalent on April 9, 1991. The device falls under product code FKP (System, Dialysate Delivery, Single Patient), a Class II device regulated under 21 CFR 876.5820. Cd Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1991
Date Received
January 17, 1991
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

Other clearances by Cd Medical, Inc.

  • K925654 — CD HOME DIALYSERVICE HEMODIALYSIS TRAY (March 30, 1994)
  • K901520 — WURTZ CHOLEY CLIP (TM) (June 26, 1990)
  • K894106 — DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST (November 8, 1989)
  • K884353 — ULTRX(TM) 850 ARTIFICIAL KIDNEY (December 8, 1988)
  • K880459 — 480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE (April 13, 1988)
  • K873279 — 8810 PUMP-PUMP SINGLE NEEDLE DEVICE (October 23, 1987)
  • K864784 — SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS (January 20, 1987)
  • K862304 — DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM (September 9, 1986)
  • K853513 — DRAKE WILLOCK 480 UF CONTROL IDALYSATE DELIVERY SY (November 6, 1985)
  • K844185 — MODIFIED C-DAK (January 3, 1985)

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)
  • K021060 — FRESENIUS ICARE MONITORING SYSTEM (November 13, 2002)
  • 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)

FDA data resources