Panels › Gastroenterology, Urology › Product code FKP · Class 2
System, Dialysate Delivery, Single Patient
Regulation 876.5820
0510(k)s in 12 months (50 all time)
0recalls in 12 months (12 all time)
12recalls that name a 510(k)
Top companies in FKP
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 26, 2018 | K181991 | NxStage Connected Health System Nxstage Medical, Inc. | FKP |
| Oct 10, 2013 | K131739 | NXSTAGE CONNECTED HEALTH SYSTEM Nxstage Medical, Inc. | FKP |
| Jul 11, 2013 | K130460 | NXSTAGE DOSING CALCULATOR Nxstage Medical, Inc. | FKP |
| Apr 8, 2004 | K040074 | ONEVIEW INTERFACE Nxstage Medical, Inc. | FKP |
| Nov 13, 2002 | K021060 | FRESENIUS ICARE MONITORING SYSTEM Fresenius Medical Care North America | FKP |
| Feb 1, 2001 | K003615 | STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS Environmental Test Systems, Inc. | FKP |
| Nov 30, 1999 | K992255 | CKHEMO, MODEL CKHEMO VERSION 1.0 Csam, Inc. | FKP |
| Jun 16, 1997 | K964264 | HIGH RANGE PEROXIDE TEST STRIP Integrated Biomedical Technology, Inc. | FKP |
| Jun 13, 1996 | K955423 | PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM Fresenius USA, Inc. | FKP |
| Mar 11, 1996 | K953854 | WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE Integrated Biomedical Technology, Inc. | FKP |
| Nov 29, 1995 | K930181 | BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE Fresenius USA, Inc. | FKP |
| Feb 13, 1995 | K922757 | SPS 1550 SINGLE NEEDLE PATIENT SYSTEM Baxter Healthcare Corp | FKP |
| Apr 20, 1994 | K921456 | FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM Fresenius USA, Inc. | FKP |
| Apr 9, 1991 | K910215 | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST Cd Medical, Inc. | FKP |
| Feb 12, 1991 | K905793 | COBE CENTRY 2 BICART OPTION KIT Cobe Laboratories, Inc. | FKP |
| Feb 11, 1991 | K905388 | COBE CENTRYSYSTEM 3 BICART OPTION KIT Cobe Laboratories, Inc. | FKP |
| Jan 28, 1991 | K904967 | HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL Gambro-Hosp-Cobe, Inc. | FKP |
| Sep 28, 1990 | K896758 | GAMBRO BICARBONATE MONITOR BCM 10-3 Gambro, Inc. | FKP |
| Aug 30, 1990 | K896757 | GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS Gambro, Inc. | FKP |
| Sep 7, 1989 | K894838 | HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB Baxter Healthcare Corp | FKP |
| May 11, 1989 | K890824 | FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM Fresenius USA, Inc. | FKP |
| Feb 8, 1989 | K883111 | HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650 Baxter Healthcare Corp | FKP |
| Apr 13, 1988 | K880459 | 480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE Cd Medical, Inc. | FKP |
| Oct 26, 1987 | K873155 | GAMBRO BICART SYSTEM Gambro, Inc. | FKP |
| Apr 30, 1987 | K871218 | MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT Hospal Medical Corp. | FKP |
| Feb 25, 1987 | K863609 | SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22 International Medical Products, Inc. | FKP |
| Nov 7, 1986 | K864094 | GAMBRO FLUID CONTROL MONITOR FCM 10-1 Gambro, Inc. | FKP |
| Nov 6, 1986 | K864083 | GAMBRO BICARBONATE MONITOR BCM 10-2 Gambro, Inc. | FKP |
| Apr 25, 1986 | K861230 | MONITRAL S Hospal Medical Corp. | FKP |
| Dec 16, 1985 | K854479 | BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH Nipro Company, Ltd., JP | FKP |
| Dec 16, 1985 | K854367 | HD-SECURA HEMADIALYSIS MACHINE Organon Teknika Corp. | FKP |
| Nov 6, 1985 | K853513 | DRAKE WILLOCK 480 UF CONTROL IDALYSATE DELIVERY SY Cd Medical, Inc. | FKP |
| Jun 12, 1985 | K851306 | COBE SYSTEM 3 Cobe Laboratories, Inc. | FKP |
| Mar 12, 1985 | K850569 | BSM 2000 DIALYSIS MACHINE - MODIFIED Organon Teknika Corp. | FKP |
| Feb 28, 1985 | K850179 | MBM(TM) MONITRAL (R) BICARBONATE MODULE Hospal Medical Corp. | FKP |
| Jun 23, 1982 | K813432 | HEMODIALYSIS SYSTEM Fhk | FKP |
| Nov 16, 1981 | K811972 | EXTRASENSR ULTRAFILTRATION MONITOR Extracorporeal Medical Specialities, Inc. | FKP |
| Jul 10, 1981 | K811591 | B-D DRAKE WILLOCK #7000 SERIES ULTRAF Bd Becton Dickinson Vacutainer Systems Preanalytic | FKP |
| Dec 17, 1980 | K802880 | EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS Extracorporeal Medical Specialities, Inc. | FKP |
| Dec 10, 1980 | K802250 | DIALYSIS CONTROL UNIT-CENTRY 2000 Cobe Laboratories, Inc. | FKP |
| Apr 8, 1980 | K800425 | GAMBRO AK-10-UDM-10-A ULTRADIFFUSION Gambro, Inc. | FKP |
| Apr 8, 1980 | K800330 | MODEL 7200 HEMODIALYSIS DELIVERY SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic | FKP |
| Nov 16, 1979 | K792173 | MODELS DM-360 & DM-350-L SINGLE PATIENT Extracorporeal Medical Specialities, Inc. | FKP |
| Jan 17, 1979 | K781886 | DIALYSATE DELIVERY SYSTEM Cordis Corp. | FKP |
| Dec 7, 1978 | K781405 | SUITCASE KIDNEY HEMODIALYSIS SYSTEM Union Carbide Corp. | FKP |
| Jun 22, 1978 | K780682 | SINGLE PATIENT SYSTEMS Extracorporeal Medical Specialities, Inc. | FKP |
| Sep 15, 1977 | K771696 | EMODIALYSIS DEL. SYS. MODEL 7110 Bd Becton Dickinson Vacutainer Systems Preanalytic | FKP |
| Jun 24, 1977 | K771065 | DYLADE, MODEL DS Milton Roy Co. Analytical | FKP |
| Mar 8, 1977 | K770350 | DIALYSIS DELIVERY SYS., ULTIM. MODEL II Vital Systems, Inc. | FKP |
| Jan 3, 1977 | K761287 | 5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY Travenol Laboratories, S.A. | FKP |
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