FDA Product Code
FDA Product Code FKP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 50 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K181991 | NxStage Connected Health System | Nxstage Medical, Inc. | 2018-09-26 | Traditional | PDF ↗ |
| K131739 | NXSTAGE CONNECTED HEALTH SYSTEM | Nxstage Medical, Inc. | 2013-10-10 | Traditional | PDF ↗ |
| K130460 | NXSTAGE DOSING CALCULATOR | Nxstage Medical, Inc. | 2013-07-11 | Traditional | PDF ↗ |
| K040074 | ONEVIEW INTERFACE | Nxstage Medical, Inc. | 2004-04-08 | Traditional | PDF ↗ |
| K021060 | FRESENIUS ICARE MONITORING SYSTEM | Fresenius Medical Care North America | 2002-11-13 | Traditional | PDF ↗ |
| K003615 | STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS | Environmental Test Systems, Inc. | 2001-02-01 | Special | PDF ↗ |
| K992255 | CKHEMO, MODEL CKHEMO VERSION 1.0 | Csam, Inc. | 1999-11-30 | Traditional | PDF ↗ |
| K964264 | HIGH RANGE PEROXIDE TEST STRIP | Integrated Biomedical Technology, Inc. | 1997-06-16 | Traditional | PDF ↗ |
| K955423 | PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM | Fresenius USA, Inc. | 1996-06-13 | Traditional | PDF ↗ |
| K953854 | WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE | Integrated Biomedical Technology, Inc. | 1996-03-11 | Traditional | PDF ↗ |
| K930181 | BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE | Fresenius USA, Inc. | 1995-11-29 | Traditional | PDF ↗ |
| K922757 | SPS 1550 SINGLE NEEDLE PATIENT SYSTEM | Baxter Healthcare Corp | 1995-02-13 | Traditional | PDF ↗ |
| K921456 | FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM | Fresenius USA, Inc. | 1994-04-20 | Traditional | PDF ↗ |
| K910215 | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST | Cd Medical, Inc. | 1991-04-09 | Traditional | PDF ↗ |
| K905793 | COBE CENTRY 2 BICART OPTION KIT | Cobe Laboratories, Inc. | 1991-02-12 | Traditional | PDF ↗ |
| K905388 | COBE CENTRYSYSTEM 3 BICART OPTION KIT | Cobe Laboratories, Inc. | 1991-02-11 | Traditional | PDF ↗ |
| K904967 | HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL | Gambro-Hosp-Cobe, Inc. | 1991-01-28 | Traditional | PDF ↗ |
| K896758 | GAMBRO BICARBONATE MONITOR BCM 10-3 | Gambro, Inc. | 1990-09-28 | Traditional | PDF ↗ |
| K896757 | GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS | Gambro, Inc. | 1990-08-30 | Traditional | PDF ↗ |
| K894838 | HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB | Baxter Healthcare Corp | 1989-09-07 | Traditional | PDF ↗ |
| K890824 | FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM | Fresenius USA, Inc. | 1989-05-11 | Traditional | PDF ↗ |
| K883111 | HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650 | Baxter Healthcare Corp | 1989-02-08 | Traditional | PDF ↗ |
| K880459 | 480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE | Cd Medical, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K873155 | GAMBRO BICART SYSTEM | Gambro, Inc. | 1987-10-26 | Traditional | PDF ↗ |
| K871218 | MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT | Hospal Medical Corp. | 1987-04-30 | Traditional | PDF ↗ |
| K863609 | SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22 | International Medical Products, Inc. | 1987-02-25 | Traditional | PDF ↗ |
| K864094 | GAMBRO FLUID CONTROL MONITOR FCM 10-1 | Gambro, Inc. | 1986-11-07 | Traditional | PDF ↗ |
| K864083 | GAMBRO BICARBONATE MONITOR BCM 10-2 | Gambro, Inc. | 1986-11-06 | Traditional | PDF ↗ |
| K861230 | MONITRAL S | Hospal Medical Corp. | 1986-04-25 | Traditional | PDF ↗ |
| K854367 | HD-SECURA HEMADIALYSIS MACHINE | Organon Teknika Corp. | 1985-12-16 | Traditional | PDF ↗ |
| K854479 | BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH | Nipro Company, Ltd. | 1985-12-16 | Traditional | PDF ↗ |
| K853513 | DRAKE WILLOCK 480 UF CONTROL IDALYSATE DELIVERY SY | Cd Medical, Inc. | 1985-11-06 | Traditional | PDF ↗ |
| K851306 | COBE SYSTEM 3 | Cobe Laboratories, Inc. | 1985-06-12 | Traditional | PDF ↗ |
| K850569 | BSM 2000 DIALYSIS MACHINE - MODIFIED | Organon Teknika Corp. | 1985-03-12 | Traditional | PDF ↗ |
| K850179 | MBM(TM) MONITRAL (R) BICARBONATE MODULE | Hospal Medical Corp. | 1985-02-28 | Traditional | PDF ↗ |
| K813432 | HEMODIALYSIS SYSTEM | Fhk | 1982-06-23 | Traditional | PDF ↗ |
| K811972 | EXTRASENSR ULTRAFILTRATION MONITOR | Extracorporeal Medical Specialities, Inc. | 1981-11-16 | Traditional | PDF ↗ |
| K811591 | B-D DRAKE WILLOCK #7000 SERIES ULTRAF | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-07-10 | Traditional | PDF ↗ |
| K802880 | EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS | Extracorporeal Medical Specialities, Inc. | 1980-12-17 | Traditional | PDF ↗ |
| K802250 | DIALYSIS CONTROL UNIT-CENTRY 2000 | Cobe Laboratories, Inc. | 1980-12-10 | Traditional | PDF ↗ |
| K800425 | GAMBRO AK-10-UDM-10-A ULTRADIFFUSION | Gambro, Inc. | 1980-04-08 | Traditional | PDF ↗ |
| K800330 | MODEL 7200 HEMODIALYSIS DELIVERY SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-04-08 | Traditional | PDF ↗ |
| K792173 | MODELS DM-360 & DM-350-L SINGLE PATIENT | Extracorporeal Medical Specialities, Inc. | 1979-11-16 | Traditional | PDF ↗ |
| K781886 | DIALYSATE DELIVERY SYSTEM | Cordis Corp. | 1979-01-17 | Traditional | PDF ↗ |
| K781405 | SUITCASE KIDNEY HEMODIALYSIS SYSTEM | Union Carbide Corp. | 1978-12-07 | Traditional | PDF ↗ |
| K780682 | SINGLE PATIENT SYSTEMS | Extracorporeal Medical Specialities, Inc. | 1978-06-22 | Traditional | PDF ↗ |
| K771696 | EMODIALYSIS DEL. SYS. MODEL 7110 | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-09-15 | Traditional | PDF ↗ |
| K771065 | DYLADE, MODEL DS | Milton Roy Co. Analytical | 1977-06-24 | Traditional | PDF ↗ |
| K770350 | DIALYSIS DELIVERY SYS., ULTIM. MODEL II | Vital Systems, Inc. | 1977-03-08 | Traditional | PDF ↗ |
| K761287 | 5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY | Travenol Laboratories, S.A. | 1977-01-03 | Traditional | PDF ↗ |
Product code FKP · Class II · Gastroenterology, Urology. Data: openFDA.