System, Dialysate Delivery, Single Patient

FDA product code FKP · 50 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5820
Review panel: GU
Implant: No
Life sustaining: Yes
Third party review: No
GMP exempt: No
Clearance span: 1977-01-03 – 2018-09-26

FKP 2018-09-26

NxStage Connected Health System

Applicant Nxstage Medical, Inc.

K number K181991

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FKP 2013-10-10

NXSTAGE CONNECTED HEALTH SYSTEM

Applicant Nxstage Medical, Inc.

K number K131739

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FKP 2013-07-11

NXSTAGE DOSING CALCULATOR

Applicant Nxstage Medical, Inc.

K number K130460

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FKP 2004-04-08

ONEVIEW INTERFACE

Applicant Nxstage Medical, Inc.

K number K040074

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FKP 2002-11-13

FRESENIUS ICARE MONITORING SYSTEM

Applicant Fresenius Medical Care North America

K number K021060

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FKP 2001-02-01

STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS

Applicant Environmental Test Systems, Inc.

K number K003615

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FKP 1999-11-30

CKHEMO, MODEL CKHEMO VERSION 1.0

Applicant Csam, Inc.

K number K992255

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FKP 1997-06-16

HIGH RANGE PEROXIDE TEST STRIP

Applicant Integrated Biomedical Technology, Inc.

K number K964264

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FKP 1996-06-13

PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM

Applicant Fresenius USA, Inc.

K number K955423

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FKP 1996-03-11

WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE

Applicant Integrated Biomedical Technology, Inc.

K number K953854

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FKP 1995-11-29

BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE

Applicant Fresenius USA, Inc.

K number K930181

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FKP 1995-02-13

SPS 1550 SINGLE NEEDLE PATIENT SYSTEM

Applicant Baxter Healthcare Corp

K number K922757

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FKP 1994-04-20

FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM

Applicant Fresenius USA, Inc.

K number K921456

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FKP 1991-04-09

DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST

Applicant Cd Medical, Inc.

K number K910215

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FKP 1991-02-12

COBE CENTRY 2 BICART OPTION KIT

Applicant Cobe Laboratories, Inc.

K number K905793

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FKP 1991-02-11

COBE CENTRYSYSTEM 3 BICART OPTION KIT

Applicant Cobe Laboratories, Inc.

K number K905388

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FKP 1991-01-28

HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL

Applicant Gambro-Hosp-Cobe, Inc.

K number K904967

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FKP 1990-09-28

GAMBRO BICARBONATE MONITOR BCM 10-3

Applicant Gambro, Inc.

K number K896758

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FKP 1990-08-30

GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS

Applicant Gambro, Inc.

K number K896757

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FKP 1989-09-07

HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB

Applicant Baxter Healthcare Corp

K number K894838

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FKP 1989-05-11

FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM

Applicant Fresenius USA, Inc.

K number K890824

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FKP 1989-02-08

HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650

Applicant Baxter Healthcare Corp

K number K883111

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FKP 1988-04-13

480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE

Applicant Cd Medical, Inc.

K number K880459

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FKP 1987-10-26

GAMBRO BICART SYSTEM

Applicant Gambro, Inc.

K number K873155

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FKP 1987-04-30

MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT

Applicant Hospal Medical Corp.

K number K871218

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FKP 1987-02-25

SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22

Applicant International Medical Products, Inc.

K number K863609

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FKP 1986-11-07

GAMBRO FLUID CONTROL MONITOR FCM 10-1

Applicant Gambro, Inc.

K number K864094

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FKP 1986-11-06

GAMBRO BICARBONATE MONITOR BCM 10-2

Applicant Gambro, Inc.

K number K864083

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FKP 1986-04-25

MONITRAL S

Applicant Hospal Medical Corp.

K number K861230

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FKP 1985-12-16

BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH

Applicant Nipro Company, Ltd.

K number K854479

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FKP 1985-12-16

HD-SECURA HEMADIALYSIS MACHINE

Applicant Organon Teknika Corp.

K number K854367

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FKP 1985-11-06

DRAKE WILLOCK 480 UF CONTROL IDALYSATE DELIVERY SY

Applicant Cd Medical, Inc.

K number K853513

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FKP 1985-06-12

COBE SYSTEM 3

Applicant Cobe Laboratories, Inc.

K number K851306

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FKP 1985-03-12

BSM 2000 DIALYSIS MACHINE - MODIFIED

Applicant Organon Teknika Corp.

K number K850569

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FKP 1985-02-28

MBM(TM) MONITRAL (R) BICARBONATE MODULE

Applicant Hospal Medical Corp.

K number K850179

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FKP 1982-06-23

HEMODIALYSIS SYSTEM

Applicant Fhk

K number K813432

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FKP 1981-11-16

EXTRASENSR ULTRAFILTRATION MONITOR

Applicant Extracorporeal Medical Specialities, Inc.

K number K811972

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FKP 1981-07-10

B-D DRAKE WILLOCK #7000 SERIES ULTRAF

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K811591

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FKP 1980-12-17

EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS

Applicant Extracorporeal Medical Specialities, Inc.

K number K802880

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FKP 1980-12-10

DIALYSIS CONTROL UNIT-CENTRY 2000

Applicant Cobe Laboratories, Inc.

K number K802250

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FKP 1980-04-08

GAMBRO AK-10-UDM-10-A ULTRADIFFUSION

Applicant Gambro, Inc.

K number K800425

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FKP 1980-04-08

MODEL 7200 HEMODIALYSIS DELIVERY SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K800330

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FKP 1979-11-16

MODELS DM-360 & DM-350-L SINGLE PATIENT

Applicant Extracorporeal Medical Specialities, Inc.

K number K792173

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FKP 1979-01-17

DIALYSATE DELIVERY SYSTEM

Applicant Cordis Corp.

K number K781886

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FKP 1978-12-07

SUITCASE KIDNEY HEMODIALYSIS SYSTEM

Applicant Union Carbide Corp.

K number K781405

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FKP 1978-06-22

SINGLE PATIENT SYSTEMS

Applicant Extracorporeal Medical Specialities, Inc.

K number K780682

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FKP 1977-09-15

EMODIALYSIS DEL. SYS. MODEL 7110

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K771696

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FKP 1977-06-24

DYLADE, MODEL DS

Applicant Milton Roy Co. Analytical

K number K771065

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FKP 1977-03-08

DIALYSIS DELIVERY SYS., ULTIM. MODEL II

Applicant Vital Systems, Inc.

K number K770350

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FKP 1977-01-03

5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY

Applicant Travenol Laboratories, S.A.

K number K761287

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