Product code FKP
- Device name
- System, Dialysate Delivery, Single Patient
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5820
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K181991 | NxStage Connected Health System | Nxstage Medical, Inc. | 2018-09-26 |
| K131739 | NXSTAGE CONNECTED HEALTH SYSTEM | Nxstage Medical, Inc. | 2013-10-10 |
| K130460 | NXSTAGE DOSING CALCULATOR | Nxstage Medical, Inc. | 2013-07-11 |
| K040074 | ONEVIEW INTERFACE | Nxstage Medical, Inc. | 2004-04-08 |
| K021060 | FRESENIUS ICARE MONITORING SYSTEM | Fresenius Medical Care North America | 2002-11-13 |
| K003615 | STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS | Environmental Test Systems, Inc. | 2001-02-01 |
| K992255 | CKHEMO, MODEL CKHEMO VERSION 1.0 | Csam, Inc. | 1999-11-30 |
| K964264 | HIGH RANGE PEROXIDE TEST STRIP | Integrated Biomedical Technology, Inc. | 1997-06-16 |
| K955423 | PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM | Fresenius USA, Inc. | 1996-06-13 |
| K953854 | WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE | Integrated Biomedical Technology, Inc. | 1996-03-11 |
| K930181 | BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE | Fresenius USA, Inc. | 1995-11-29 |
| K922757 | SPS 1550 SINGLE NEEDLE PATIENT SYSTEM | Baxter Healthcare Corp | 1995-02-13 |
| K921456 | FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM | Fresenius USA, Inc. | 1994-04-20 |
| K910215 | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST | Cd Medical, Inc. | 1991-04-09 |
| K905793 | COBE CENTRY 2 BICART OPTION KIT | Cobe Laboratories, Inc. | 1991-02-12 |
| K905388 | COBE CENTRYSYSTEM 3 BICART OPTION KIT | Cobe Laboratories, Inc. | 1991-02-11 |
| K904967 | HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL | Gambro-Hosp-Cobe, Inc. | 1991-01-28 |
| K896758 | GAMBRO BICARBONATE MONITOR BCM 10-3 | Gambro, Inc. | 1990-09-28 |
| K896757 | GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS | Gambro, Inc. | 1990-08-30 |
| K894838 | HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB | Baxter Healthcare Corp | 1989-09-07 |
| K890824 | FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM | Fresenius USA, Inc. | 1989-05-11 |
| K883111 | HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650 | Baxter Healthcare Corp | 1989-02-08 |
| K880459 | 480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE | Cd Medical, Inc. | 1988-04-13 |
| K873155 | GAMBRO BICART SYSTEM | Gambro, Inc. | 1987-10-26 |
| K871218 | MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT | Hospal Medical Corp. | 1987-04-30 |
| K863609 | SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22 | International Medical Products, Inc. | 1987-02-25 |
| K864094 | GAMBRO FLUID CONTROL MONITOR FCM 10-1 | Gambro, Inc. | 1986-11-07 |
| K864083 | GAMBRO BICARBONATE MONITOR BCM 10-2 | Gambro, Inc. | 1986-11-06 |
| K861230 | MONITRAL S | Hospal Medical Corp. | 1986-04-25 |
| K854367 | HD-SECURA HEMADIALYSIS MACHINE | Organon Teknika Corp. | 1985-12-16 |
Related GUDID Devices#
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|---|---|---|---|
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| G212CP20101 | WaterCheckCP | Ibt Scientific LLC | 2022-01-06 |
| G212PX20501 | RenalCheck PX | Ibt Scientific LLC | 2022-01-06 |
| G212RC22101 | WaterCheckRC | Ibt Scientific LLC | 2022-01-06 |
| G212HP20401 | Peracid Test | Ibt Scientific LLC | 2022-01-06 |
| 00842289101883 | NX2ME APP | NXSTAGE MEDICAL, INC. | 2019-02-15 |
| 00842289101890 | NX2ME CLINICIAN PORTAL | NXSTAGE MEDICAL, INC. | 2019-02-15 |
| M535NX1225NX1379 | Nx2me Connected Health Nx2me App | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| M535NX1225NX1380 | Nx2me Connected Health Nx2me Clinician Portal | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| M535NX1272 | NxStage Dosing Calculator | NXSTAGE MEDICAL, INC. | 2015-09-01 |