FKQ · Class II · 21 CFR 876.5820

FDA Product Code FKQ: System, Dialysate Delivery, Central Multiple Patient

Leading manufacturers include Hospal Medical Corp., Travenol Laboratories, S.A. and Renal Systems, Inc..

61
Total
61
Cleared
81d
Avg days
1976
Since

FDA 510(k) Cleared System, Dialysate Delivery, Central Multiple Patient Devices (Product Code FKQ)

61 devices
1–24 of 61
Cleared Jun 09, 2006
DIACAP ULTRA DIALYSIS FLUID FILTER
K052764
B. Braun Medizintechnologie GmbH
Gastroenterology & Urology · 252d
Cleared Jul 24, 1989
TWO TANK DISSOLUTION MODULE
K893612
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 75d
Cleared Apr 27, 1988
MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM
K874084
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 203d
Cleared Oct 09, 1987
KAWASUMI A.V. FISTULA SET
K873421
Kawasumi Laboratories Co., Ltd.
Gastroenterology & Urology · 45d
Cleared Jul 08, 1987
ACID FUCHSIN SOLUTIONS
K870889
D.R.G. Scientific Industries
Gastroenterology & Urology · 125d
Cleared Jun 09, 1987
ACTRIL FOR KIDNEY MACHINE DISINFECTANT
K861730
Renal Systems, Inc.
Gastroenterology & Urology · 399d
Cleared Jan 13, 1987
FOUR TANK DISSOLUTION MODULE
K864635
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 49d
Cleared Sep 09, 1986
DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM
K862304
Cd Medical, Inc.
Gastroenterology & Urology · 84d
Cleared Jul 10, 1986
MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445
K861472
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 79d
Cleared May 13, 1986
AMUCHINA/DIALYZER DISINFECTANT
K852359
Amuchina Intl., Inc.
Gastroenterology & Urology · 343d
Cleared Mar 04, 1986
HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES
K860296
Physicians Surgeons Purchasing Group
Gastroenterology & Urology · 35d
Cleared Mar 04, 1986
HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES
K860297
Renal Hygienics
Gastroenterology & Urology · 35d
Cleared Mar 04, 1986
HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS
K860336
Breem Laboratories
Gastroenterology & Urology · 34d
Cleared Jan 08, 1986
HEMODIALYSIS CONCENTRATE
K854391
Dana Laboratories
Gastroenterology & Urology · 69d
Cleared Sep 10, 1985
RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT
K852749
Mesa Medical, Inc.
Gastroenterology & Urology · 75d
Cleared Jul 26, 1985
NATURALYTE BICARBONATE CONCENTRATE-DRY PACK
K852310
Erika, Inc.
Gastroenterology & Urology · 58d
Cleared May 17, 1985
ALCIDE REN NEW-D
K844734
Alcide Corp.
Gastroenterology & Urology · 164d
Cleared Apr 02, 1985
MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT
K844850
Medicorp, Inc.
Gastroenterology & Urology · 110d
Cleared Feb 15, 1985
FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD
K844750
Seratronics, Inc.
Gastroenterology & Urology · 71d
Cleared Feb 14, 1985
FRESENIUS HAEMODIALYSIS
K844641
Seratronics, Inc.
Gastroenterology & Urology · 78d
Cleared Jan 22, 1985
NEPHROSS ALLEGRO H.F.
K844748
Organon Teknika Corp.
Gastroenterology & Urology · 47d
Cleared Jan 16, 1985
ST FAMILY OF HOLLOW FIBER DIALYZERS
K844756
Travenol Laboratories, S.A.
Gastroenterology & Urology · 42d
Cleared Jan 07, 1985
DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD
K843963
Renal Systems, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 16, 1984
UNILYTE A
K843623
Medical Enterprises, Ltd.
Gastroenterology & Urology · 87d

About Product Code FKQ - Regulatory Context