Product code FKP— Gastroenterology, Urology
480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE
- Classification name
- System, Dialysate Delivery, Single Patient
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 50
- First cleared
- Most recent
Market context for product code FKP
FDA has cleared devices under product code FKP between 1977 and 2018, filed by 23 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2018
- 2013
- 2004
- 2002
- 2001
- 1999
- 1997
- 1996
- 1995
- 1994
- 1991
- 1990
- 1989
- 1988
- 1987
Top applicants under product code FKP
Recent clearances under product code FKP
- K181991 — NxStage Connected Health System
- K131739 — NXSTAGE CONNECTED HEALTH SYSTEM
- K130460 — NXSTAGE DOSING CALCULATOR
- K040074 — ONEVIEW INTERFACE
- K021060 — FRESENIUS ICARE MONITORING SYSTEM
- K003615 — STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS
- K992255 — CKHEMO, MODEL CKHEMO VERSION 1.0
- K964264 — HIGH RANGE PEROXIDE TEST STRIP
- K955423 — PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
- K953854 — WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE
- K930181 — BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE
- K922757 — SPS 1550 SINGLE NEEDLE PATIENT SYSTEM
- K921456 — FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM
- K910215 — DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST
- K905793 — COBE CENTRY 2 BICART OPTION KIT
- K905388 — COBE CENTRYSYSTEM 3 BICART OPTION KIT
- K904967 — HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL
- K896758 — GAMBRO BICARBONATE MONITOR BCM 10-3
- K896757 — GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS
- K894838 — HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB
- K890824 — FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM
- K883111 — HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650
- K880459 — 480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE
- K873155 — GAMBRO BICART SYSTEM
- K871218 — MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT
- K863609 — SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22
- K864094 — GAMBRO FLUID CONTROL MONITOR FCM 10-1
- K864083 — GAMBRO BICARBONATE MONITOR BCM 10-2
- K861230 — MONITRAL S
- K854367 — HD-SECURA HEMADIALYSIS MACHINE
- K854479 — BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH
- K853513 — DRAKE WILLOCK 480 UF CONTROL IDALYSATE DELIVERY SY
- K851306 — COBE SYSTEM 3
- K850569 — BSM 2000 DIALYSIS MACHINE - MODIFIED
- K850179 — MBM(TM) MONITRAL (R) BICARBONATE MODULE
- K813432 — HEMODIALYSIS SYSTEM
- K811972 — EXTRASENSR ULTRAFILTRATION MONITOR
- K811591 — B-D DRAKE WILLOCK #7000 SERIES ULTRAF
- K802880 — EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS
- K802250 — DIALYSIS CONTROL UNIT-CENTRY 2000
- K800330 — MODEL 7200 HEMODIALYSIS DELIVERY SYSTEM
- K800425 — GAMBRO AK-10-UDM-10-A ULTRADIFFUSION
- K792173 — MODELS DM-360 & DM-350-L SINGLE PATIENT
- K781886 — DIALYSATE DELIVERY SYSTEM
- K781405 — SUITCASE KIDNEY HEMODIALYSIS SYSTEM
- K780682 — SINGLE PATIENT SYSTEMS
- K771696 — EMODIALYSIS DEL. SYS. MODEL 7110
- K771065 — DYLADE, MODEL DS
- K770350 — DIALYSIS DELIVERY SYS., ULTIM. MODEL II
- K761287 — 5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY
Data sourced from openFDA. This site is unofficial and independent of the FDA.