Product Code: FKP FDA class 2 21 CFR 876.5820

System, Dialysate Delivery, Single Patient

Gastroenterology, Urology

The Single-Patient Dialysate Delivery System is a machine or system that prepares and delivers dialysate solution to an individual patient's hemodialysis circuit during treatment. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FKP, regulated under 21 CFR 876.5820 in the Gastroenterology and Urology specialty. This device is designated as life sustaining or life supporting.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FKP
Device Class: FDA class 2
Regulation Number: 876.5820
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 50 510(k) clearances via K numbers.

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