Atlas FDA

FKP

50 FDA 510(k) clearances · Product code

73 daysmedian time to decision
272 days90th percentile
50clearances measured

FDA profile

Official device name
System, Dialysate Delivery, Single Patient
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5820
Medical specialty
Gastroenterology, Urology
Flags
Life-sustaining
Adverse events (MAUDE)
2005: 59 · 2006: 17 · 2007: 8 · 2008: 26 · 2009: 22 · 2010: 9
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
NxStage Connected Health System (K181991)Nxstage Medical, Inc.2018-09-26
NXSTAGE CONNECTED HEALTH SYSTEM (K131739)Nxstage Medical, Inc.2013-10-10
NXSTAGE DOSING CALCULATOR (K130460)Nxstage Medical, Inc.2013-07-11
ONEVIEW INTERFACE (K040074)Nxstage Medical, Inc.2004-04-08
FRESENIUS ICARE MONITORING SYSTEM (K021060)Fresenius Medical Care North America2002-11-13
STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS (K003615)Environmental Test Systems, Inc.2001-02-01
CKHEMO, MODEL CKHEMO VERSION 1.0 (K992255)Csam, Inc.1999-11-30
HIGH RANGE PEROXIDE TEST STRIP (K964264)Integrated Biomedical Technology, Inc.1997-06-16
PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (K955423)Fresenius USA, Inc.1996-06-13
WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE (K953854)Integrated Biomedical Technology, Inc.1996-03-11
BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE (K930181)Fresenius USA, Inc.1995-11-29
SPS 1550 SINGLE NEEDLE PATIENT SYSTEM (K922757)Baxter Healthcare Corp1995-02-13
FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM (K921456)Fresenius USA, Inc.1994-04-20
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST (K910215)Cd Medical, Inc.1991-04-09
COBE CENTRY 2 BICART OPTION KIT (K905793)Cobe Laboratories, Inc.1991-02-12
COBE CENTRYSYSTEM 3 BICART OPTION KIT (K905388)Cobe Laboratories, Inc.1991-02-11
HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL (K904967)Gambro-Hosp-Cobe, Inc.1991-01-28
GAMBRO BICARBONATE MONITOR BCM 10-3 (K896758)Gambro, Inc.1990-09-28
GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS (K896757)Gambro, Inc.1990-08-30
HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB (K894838)Baxter Healthcare Corp1989-09-07
FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM (K890824)Fresenius USA, Inc.1989-05-11
HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650 (K883111)Baxter Healthcare Corp1989-02-08
480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE (K880459)Cd Medical, Inc.1988-04-13
GAMBRO BICART SYSTEM (K873155)Gambro, Inc.1987-10-26
MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT (K871218)Hospal Medical Corp.1987-04-30
SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22 (K863609)International Medical Products, Inc.1987-02-25
GAMBRO FLUID CONTROL MONITOR FCM 10-1 (K864094)Gambro, Inc.1986-11-07
GAMBRO BICARBONATE MONITOR BCM 10-2 (K864083)Gambro, Inc.1986-11-06
MONITRAL S (K861230)Hospal Medical Corp.1986-04-25
BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH (K854479)Nipro Company, Ltd.1985-12-16
HD-SECURA HEMADIALYSIS MACHINE (K854367)Organon Teknika Corp.1985-12-16
DRAKE WILLOCK 480 UF CONTROL IDALYSATE DELIVERY SY (K853513)Cd Medical, Inc.1985-11-06
COBE SYSTEM 3 (K851306)Cobe Laboratories, Inc.1985-06-12
BSM 2000 DIALYSIS MACHINE - MODIFIED (K850569)Organon Teknika Corp.1985-03-12
MBM(TM) MONITRAL (R) BICARBONATE MODULE (K850179)Hospal Medical Corp.1985-02-28
HEMODIALYSIS SYSTEM (K813432)Fhk1982-06-23
EXTRASENSR ULTRAFILTRATION MONITOR (K811972)Extracorporeal Medical Specialities, Inc.1981-11-16
B-D DRAKE WILLOCK #7000 SERIES ULTRAF (K811591)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-07-10
EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS (K802880)Extracorporeal Medical Specialities, Inc.1980-12-17
DIALYSIS CONTROL UNIT-CENTRY 2000 (K802250)Cobe Laboratories, Inc.1980-12-10
MODEL 7200 HEMODIALYSIS DELIVERY SYSTEM (K800330)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-04-08
GAMBRO AK-10-UDM-10-A ULTRADIFFUSION (K800425)Gambro, Inc.1980-04-08
MODELS DM-360 & DM-350-L SINGLE PATIENT (K792173)Extracorporeal Medical Specialities, Inc.1979-11-16
DIALYSATE DELIVERY SYSTEM (K781886)Cordis Corp.1979-01-17
SUITCASE KIDNEY HEMODIALYSIS SYSTEM (K781405)Union Carbide Corp.1978-12-07
SINGLE PATIENT SYSTEMS (K780682)Extracorporeal Medical Specialities, Inc.1978-06-22
EMODIALYSIS DEL. SYS. MODEL 7110 (K771696)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-09-15
DYLADE, MODEL DS (K771065)Milton Roy Co. Analytical1977-06-24
DIALYSIS DELIVERY SYS., ULTIM. MODEL II (K770350)Vital Systems, Inc.1977-03-08
5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY (K761287)Travenol Laboratories, S.A.1977-01-03

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Every clearance here is in the API, with alerts when new ones post.