FKP · Class II · 21 CFR 876.5820

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

Leading manufacturers include Gambro, Inc., Cobe Laboratories, Inc. and Nxstage Medical, Inc..

50
Total
50
Cleared
141d
Avg days
1977
Since
50 devices
25–48 of 50
Cleared Apr 30, 1987
MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT
K871218
Hospal Medical Corp.
Gastroenterology & Urology · 34d
Cleared Feb 25, 1987
SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22
K863609
International Medical Products, Inc.
Gastroenterology & Urology · 162d
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 Dec 16, 1985
BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH
K854479
Nipro Company, Ltd.
Gastroenterology & Urology · 39d
Cleared Nov 06, 1985
DRAKE WILLOCK 480 UF CONTROL IDALYSATE DELIVERY SY
K853513
Cd Medical, Inc.
Gastroenterology & Urology · 77d
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
Cleared Feb 28, 1985
MBM(TM) MONITRAL (R) BICARBONATE MODULE
K850179
Hospal Medical Corp.
Gastroenterology & Urology · 42d
Cleared Jun 23, 1982
HEMODIALYSIS SYSTEM
K813432
Fhk
Gastroenterology & Urology · 197d
Cleared Nov 16, 1981
EXTRASENSR ULTRAFILTRATION MONITOR
K811972
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 129d
Cleared Jul 10, 1981
B-D DRAKE WILLOCK #7000 SERIES ULTRAF
K811591
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 32d
Cleared Dec 17, 1980
EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS
K802880
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 30d
Cleared Dec 10, 1980
DIALYSIS CONTROL UNIT-CENTRY 2000
K802250
Cobe Laboratories, Inc.
Gastroenterology & Urology · 85d
Cleared Apr 08, 1980
MODEL 7200 HEMODIALYSIS DELIVERY SYSTEM
K800330
Bd Becton Dickinson Vacutainer Systems Preanalytic
Gastroenterology & Urology · 55d
Cleared Apr 08, 1980
GAMBRO AK-10-UDM-10-A ULTRADIFFUSION
K800425
Gambro, Inc.
Gastroenterology & Urology · 42d
Cleared Nov 16, 1979
MODELS DM-360 & DM-350-L SINGLE PATIENT
K792173
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 18d
Cleared Jan 17, 1979
DIALYSATE DELIVERY SYSTEM
K781886
Cordis Corp.
Gastroenterology & Urology · 71d
Cleared Dec 07, 1978
SUITCASE KIDNEY HEMODIALYSIS SYSTEM
K781405
Union Carbide Corp.
Gastroenterology & Urology · 115d
Cleared Jun 22, 1978
SINGLE PATIENT SYSTEMS
K780682
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 59d
Cleared Sep 15, 1977
EMODIALYSIS DEL. SYS. MODEL 7110
K771696
Bd Becton Dickinson Vacutainer Systems Preanalytic
Gastroenterology & Urology · 9d
Cleared Jun 24, 1977
DYLADE, MODEL DS
K771065
Milton Roy Co. Analytical
Gastroenterology & Urology · 11d