FKP · Class II · 21 CFR 876.5820

FDA Product Code FKP: System, Dialysate Delivery, Single Patient

Leading manufacturers include Gambro, Inc., Nxstage Medical, Inc. and Extracorporeal Medical Specialities, Inc..

50
Total
50
Cleared
141d
Avg days
1977
Since

FDA 510(k) Cleared System, Dialysate Delivery, Single Patient Devices (Product Code FKP)

50 devices
1–24 of 50
Cleared Sep 26, 2018
NxStage Connected Health System
K181991
Nxstage Medical, Inc.
Gastroenterology & Urology · 62d
Cleared Oct 10, 2013
NXSTAGE CONNECTED HEALTH SYSTEM
K131739
Nxstage Medical, Inc.
Gastroenterology & Urology · 119d
Cleared Jul 11, 2013
NXSTAGE DOSING CALCULATOR
K130460
Nxstage Medical, Inc.
Gastroenterology & Urology · 139d
Cleared Apr 08, 2004
ONEVIEW INTERFACE
K040074
Nxstage Medical, Inc.
Gastroenterology & Urology · 85d
Cleared Nov 13, 2002
FRESENIUS ICARE MONITORING SYSTEM
K021060
Fresenius Medical Care North America
Gastroenterology & Urology · 225d
Cleared Jun 13, 1996
PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
K955423
Fresenius USA, Inc.
Gastroenterology & Urology · 198d
Cleared Nov 29, 1995
BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE
K930181
Fresenius USA, Inc.
Gastroenterology & Urology · 1049d
Cleared Feb 13, 1995
SPS 1550 SINGLE NEEDLE PATIENT SYSTEM
K922757
Baxter Healthcare Corp
Gastroenterology & Urology · 979d
Cleared Apr 20, 1994
FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM
K921456
Fresenius USA, Inc.
Gastroenterology & Urology · 754d
Cleared Feb 12, 1991
COBE CENTRY 2 BICART OPTION KIT
K905793
Cobe Laboratories, Inc.
Gastroenterology & Urology · 47d
Cleared Feb 11, 1991
COBE CENTRYSYSTEM 3 BICART OPTION KIT
K905388
Cobe Laboratories, Inc.
Gastroenterology & Urology · 73d
Cleared Sep 28, 1990
GAMBRO BICARBONATE MONITOR BCM 10-3
K896758
Gambro, Inc.
Gastroenterology & Urology · 301d
Cleared Aug 30, 1990
GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS
K896757
Gambro, Inc.
Gastroenterology & Urology · 272d
Cleared Sep 07, 1989
HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB
K894838
Baxter Healthcare Corp
Gastroenterology & Urology · 38d
Cleared May 11, 1989
FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM
K890824
Fresenius USA, Inc.
Gastroenterology & Urology · 83d
Cleared Feb 08, 1989
HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650
K883111
Baxter Healthcare Corp
Gastroenterology & Urology · 198d
Cleared Oct 26, 1987
GAMBRO BICART SYSTEM
K873155
Gambro, Inc.
Gastroenterology & Urology · 77d
Cleared Apr 30, 1987
MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT
K871218
Hospal Medical Corp.
Gastroenterology & Urology · 34d
Cleared Nov 07, 1986
GAMBRO FLUID CONTROL MONITOR FCM 10-1
K864094
Gambro, Inc.
Gastroenterology & Urology · 17d
Cleared Nov 06, 1986
GAMBRO BICARBONATE MONITOR BCM 10-2
K864083
Gambro, Inc.
Gastroenterology & Urology · 17d
Cleared Apr 25, 1986
MONITRAL S
K861230
Hospal Medical Corp.
Gastroenterology & Urology · 24d
Cleared Dec 16, 1985
HD-SECURA HEMADIALYSIS MACHINE
K854367
Organon Teknika Corp.
Gastroenterology & Urology · 48d
Cleared Jun 12, 1985
COBE SYSTEM 3
K851306
Cobe Laboratories, Inc.
Gastroenterology & Urology · 72d
Cleared Mar 12, 1985
BSM 2000 DIALYSIS MACHINE - MODIFIED
K850569
Organon Teknika Corp.
Gastroenterology & Urology · 28d

About Product Code FKP - Regulatory Context