Product Code: FKQ FDA class 2 21 CFR 876.5820

System, Dialysate Delivery, Central Multiple Patient

Gastroenterology, Urology

The Central Multiple-Patient Dialysate Delivery System is a centralized system that prepares and distributes dialysate solution to multiple hemodialysis stations simultaneously within a dialysis facility. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FKQ, 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: FKQ
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 61 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K052764	DIACAP ULTRA DIALYSIS FLUID FILTER	Jun 09, 2006	Substantially Equivalent	B. Braun Medizintechnologie GmbH
K893612	TWO TANK DISSOLUTION MODULE	Jul 24, 1989	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K874084	MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM	Apr 27, 1988	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K873421	KAWASUMI A.V. FISTULA SET	Oct 09, 1987	Substantially Equivalent	Kawasumi Laboratories Co., Ltd.
K870889	ACID FUCHSIN SOLUTIONS	Jul 08, 1987	Substantially Equivalent	D.R.G. Scientific Industries
K861730	ACTRIL FOR KIDNEY MACHINE DISINFECTANT	Jun 09, 1987	Substantially Equivalent	Renal Systems, Inc.
K864635	FOUR TANK DISSOLUTION MODULE	Jan 13, 1987	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K862304	DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM	Sep 09, 1986	Substantially Equivalent	Cd Medical, Inc.
K861472	MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445	Jul 10, 1986	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K852359	AMUCHINA/DIALYZER DISINFECTANT	May 13, 1986	Substantially Equivalent	Amuchina Intl., Inc.
K860336	HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS	Mar 04, 1986	Substantially Equivalent	Breem Laboratories
K860297	HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES	Mar 04, 1986	Substantially Equivalent	Renal Hygienics
K860296	HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES	Mar 04, 1986	Substantially Equivalent	Physicians Surgeons Purchasing Group
K854391	HEMODIALYSIS CONCENTRATE	Jan 08, 1986	Substantially Equivalent	Dana Laboratories
K852749	RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT	Sep 10, 1985	Substantially Equivalent	Mesa Medical, Inc.
K852310	NATURALYTE BICARBONATE CONCENTRATE-DRY PACK	Jul 26, 1985	Substantially Equivalent	Erika, Inc.
K844734	ALCIDE REN NEW-D	May 17, 1985	Substantially Equivalent	Alcide Corp.
K844850	MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT	Apr 02, 1985	Substantially Equivalent	Medicorp, Inc.
K844750	FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD	Feb 15, 1985	Substantially Equivalent	Seratronics, Inc.
K844641	FRESENIUS HAEMODIALYSIS ;MACHINE A1008	Feb 14, 1985	Substantially Equivalent	Seratronics, Inc.
K844748	NEPHROSS ALLEGRO H.F.	Jan 22, 1985	Substantially Equivalent	Organon Teknika Corp.
K844756	ST FAMILY OF HOLLOW FIBER DIALYZERS	Jan 16, 1985	Substantially Equivalent	Travenol Laboratories, S.A.
K843963	DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD	Jan 07, 1985	Substantially Equivalent	Renal Systems, Inc.
K843623	UNILYTE A	Nov 16, 1984	Substantially Equivalent	Medical Enterprises, Ltd.
K842225	HEMODIAL CONCENTRATE MIXING APPARATUS	Oct 02, 1984	Substantially Equivalent	Lmf Medical Research & Manufacturing, Inc.
K842131	FORMACLEAR- & MULTIPLE	Sep 10, 1984	Substantially Equivalent	Rna Medical Corp.
K842154	PACKETS FOR THE PREP OF DIALYSATES &	Jul 31, 1984	Substantially Equivalent	Organon Teknika Corp.
K834455	MONOXYCHLOROSENE WAREXIN	Jul 31, 1984	Substantially Equivalent	Guardian Chemical
K842058	HEMODIALYSIS BATH CONCENTRATE SOLUTION	Jul 26, 1984	Substantially Equivalent	Pharmaceutical Development Systems
K842294	DIALYSATE ADDITIVES	Jun 28, 1984	Substantially Equivalent	Dialysis Products, Inc.
K841543	CONCENTRATE CONDUCTIVITY METER	May 22, 1984	Substantially Equivalent	Renal Systems, Inc.
K840182	RENAPAK CONCENTRATE MIXING SYS.	May 02, 1984	Substantially Equivalent	Renal Systems, Inc.
K834395	CHEMLYTE	Apr 20, 1984	Substantially Equivalent	Diachem Laboratories
K834587	HEMODIAL CONCENTRATE	Apr 13, 1984	Substantially Equivalent	Moana Productions, Inc.
K840814	HOSPAL MODEL H1210	Apr 02, 1984	Substantially Equivalent	Hospal Medical Corp.
K840813	BIOSPAL 1200S	Apr 02, 1984	Substantially Equivalent	Hospal Medical Corp.
K840812	BIOSPAL 2400S	Apr 02, 1984	Substantially Equivalent	Hospal Medical Corp.
K840811	BIOSPAL 3000S	Apr 02, 1984	Substantially Equivalent	Hospal Medical Corp.
K832663	GAMMA STERIL. CAPILLARY FLOW DIALY-G15	Sep 12, 1983	Substantially Equivalent	Travenol Laboratories, S.A.
K831940	GAMMA STERILIZED CAPILLARY FLOW DIALYZ	Aug 08, 1983	Substantially Equivalent	Travenol Laboratories, S.A.
K830908	BICARBONATE/VARIABLE SODIUM KIT-DM-367	Jun 08, 1983	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K823092	HEMAFLO BLOOD TUBING SETS	Nov 22, 1982	Substantially Equivalent	Cobe Laboratories, Inc.
K822851	DISSCAP 080	Oct 04, 1982	Substantially Equivalent	Hospal Medical Corp.
K822535	CIDEX*DIALYZER DISINFECTING SOLUTION	Sep 30, 1982	Substantially Equivalent	Surgikos, Inc.
K822485	HPF 100,200,300 CAPILLARY FLOW DIALYZ	Aug 30, 1982	Substantially Equivalent	Erika, Inc.
K821834	MODEL 100 BICARBONATE CONDUCTIVITY	Jul 02, 1982	Substantially Equivalent	Western Laboratories Corp.
K820966	DISSCAP 110	Apr 16, 1982	Substantially Equivalent	Hospal Medical Corp.
K820965	DISSCAP 140	Apr 16, 1982	Substantially Equivalent	Hospal Medical Corp.
K820769	GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL	Apr 16, 1982	Substantially Equivalent	Gambro, Inc.
K812330	DIALYSATE CONCENTRATE	Sep 29, 1981	Substantially Equivalent	Central Biological Co.
K811444	MODEL DM-333 DIALYSIS CONTROL STATION	Jun 23, 1981	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K802297	PORTADIAL CARRY-ON KIDNEY MACHINE	May 01, 1981	Substantially Equivalent	Alan P. Kendal, Ph.D.
K810612	HEMOPHRON	Apr 29, 1981	Substantially Equivalent	Renal Devices, Inc.
K810315	ALTERNATE STERILIZ. FOR CELLULOSE ACET	Mar 20, 1981	Substantially Equivalent	Cordis Corp.
K800771	MOD. DM-356 IPS INTERFACE MODULE	May 20, 1980	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K792252	DMS 3000	Mar 12, 1980	Substantially Equivalent	Renal Care Corp.
K781176	PATIENT AID, MODEL DM-351	Sep 07, 1978	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K780081	DIALYZING FLUIDE DELIVERY SYSTEM	Mar 31, 1978	Substantially Equivalent	Travenol Laboratories, S.A.
K772161	HEMODIALYSIS APPARATUS	Jan 03, 1978	Substantially Equivalent	Heald Manufacturing, Inc.
K771375	PRESSURE MODULE 5M1247	Sep 15, 1977	Substantially Equivalent	Travenol Laboratories, S.A.
K760965	BEDSIDE CONSOLES (11-3-910 & 11-3-930)	Dec 06, 1976	Substantially Equivalent	Seattle Artificial Kidney Supply Co.