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Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Regulation 876.5820

2510(k)s in 12 months (124 all time)

15recalls in 12 months (113 all time)

113recalls that name a 510(k)

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Top companies in KPO

Company	510(k)s	Recalls
Fresenius Medical Care Holdings, Inc.	0	59
Fresenius Medical Care Renal Therapies Group, LLC	10	12
Nxstage Medical, Inc.	6	15
Diasol, Inc.	4	8
Rockwell Medical Technologies, Inc.	5	7
Baxter Healthcare Corp	7	1
Gambro Renal Products	6	0
Nipro Renal Soultions USA, Corporation	0	6
Di-Chem, Inc.	5	0
Isopure, Corp.	2	3

Date	Firm and product	Code	Linked 510(k)
Jan 11, 2021	Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified	KPO	K070177
Jan 11, 2021	Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified	KPO	K070177
Jan 11, 2021	Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified	KPO	K070177
Jan 11, 2021	Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified	KPO	K070177
Jan 11, 2021	Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified	KPO	K070177
Jan 11, 2021	Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified	KPO	K070177
Jan 11, 2021	Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified	KPO	K070177
Jan 11, 2021	Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified	KPO	K070177
Jan 11, 2021	Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified	KPO	K070177
Dec 17, 2020	Fresenius Medical Care Holdings, Inc. Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9 Terminated	KPO	K070177
Apr 30, 2020	Diasol, Inc DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS Terminated	KPO	K851431
Jan 19, 2020	Isopure Corp Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3 Terminated	KPO	K120005
Apr 11, 2019	NxStage Medical, Inc. NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialys Terminated	KPO	K053286
Apr 11, 2019	NxStage Medical, Inc. NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during he Terminated	KPO	K053286
Oct 17, 2018	NxStage Medical, Inc. NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dia Terminated	KPO	K053286
Oct 17, 2018	NxStage Medical, Inc. NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dia Terminated	KPO	K053286
Oct 17, 2018	NxStage Medical, Inc. NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysa Terminated	KPO	K053286
Oct 17, 2018	NxStage Medical, Inc. NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysa Terminated	KPO	K053286
Oct 17, 2018	NxStage Medical, Inc. NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialys Terminated	KPO	K053286
Oct 17, 2018	NxStage Medical, Inc. NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysa Terminated	KPO	K053286
Oct 17, 2018	NxStage Medical, Inc. NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysa Terminated	KPO	K053286
Oct 17, 2018	NxStage Medical, Inc. NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialy Terminated	KPO	K053286
Oct 9, 2018	Fresenius Medical Care Renal Therapies Group, LLC Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis Terminated	KPO	K030497
Oct 9, 2018	Fresenius Medical Care Renal Therapies Group, LLC Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis Terminated	KPO	K030497
Oct 9, 2018	Fresenius Medical Care Renal Therapies Group, LLC Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis Terminated	KPO	K030497
May 2, 2018	Fresenius Medical Care Renal Therapies Group, LLC NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be used in conjunction with Fresenius Renal Technolog Terminated	KPO	K070177
Apr 7, 2018	Rockwell Medical, Inc DriSate Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicar Terminated	KPO	K981003
Nov 10, 2017	NxStage Medical, Inc. NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One Terminated	KPO	K053286
Sep 29, 2017	Fresenius Medical Care Renal Therapies Group, LLC NaturaLyte Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concen Terminated	KPO	K070177
Jun 24, 2016	Baxter Healthcare Corp. PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy Terminated	KPO	K072908
Feb 25, 2016	Fresenius Medical Care Renal Therapies Group, LLC Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis Terminated	KPO	K070177
Oct 23, 2015	Fresenius Medical Care Renal Therapies Group, LLC Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid concentrate for hemodialysis. Terminated	KPO	K131611
Oct 23, 2015	Fresenius Medical Care Renal Therapies Group, LLC Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis. Terminated	KPO	K131611
Oct 23, 2015	Fresenius Medical Care Renal Therapies Group, LLC Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis. Terminated	KPO	K911459
Aug 12, 2015	Fresenius Medical Care Holdings, Inc. Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB Open, Classified	KPO	K071387
Jun 22, 2015	Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hem Open, Classified	KPO	K071387
Sep 23, 2014	Fresenius Medical Care Holdings, Inc. Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicar Terminated	KPO	K071387
Jun 9, 2014	Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. The concentrate is formulated to be used with a three steam hemodialysis mac Terminated	KPO	K071387
May 22, 2014	Fresenius Medical Care Holdings, Inc. Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and b Open, Classified	KPO	K071387
Feb 24, 2014	NxStage Medical, Inc. NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. The NxStage PureFlow-B Solution is indicated for use with renal replace Terminated	KPO	K053286
May 2, 2013	NxStage Medical, Inc. NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premix Terminated	KPO	K042045
Jan 17, 2013	Fresenius Medical Care Holdings, Inc. Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2325-3B Product Usage: GranuFlo is indicated in the treatment of acute and Terminated	KPO	K030497
Jan 17, 2013	Fresenius Medical Care Holdings, Inc. Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1.0Mg .16.5GAL Catalog Number: OFD3201-3B Product Usage: GranuFlo is indicated in the treatment of acute and Terminated	KPO	K030497
Jan 17, 2013	Fresenius Medical Care Holdings, Inc. Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2223-3B Product Usage: GranuFlo is indicated in the treatment of acute and Terminated	KPO	K030497
Jan 17, 2013	Fresenius Medical Care Holdings, Inc. Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL Catalog Number: OFD2225-3B Product Usage: GranuFlo is indicated in the treatment of acute a Terminated	KPO	K030497
Jan 17, 2013	Fresenius Medical Care Holdings, Inc. Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD1201-3B Product Usage: GranuFlo is indicated in the treatment of acute and ch Terminated	KPO	K030497
Jan 17, 2013	Fresenius Medical Care Holdings, Inc. Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL Catalog Number: OFD2231-3B Product Usage: GranuFlo is indicated in the treatment of acute and c Terminated	KPO	K030497
Jan 17, 2013	Fresenius Medical Care Holdings, Inc. Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL Catalog Number: OFD3251-3B Product Usage: GranuFlo is indicated in the treatment of acute and ch Terminated	KPO	K030497
Jan 17, 2013	Fresenius Medical Care Holdings, Inc. Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD2201-3B Product Usage: GranuFlo is indicated in the treatment of acute and ch Terminated	KPO	K030497
Jan 17, 2013	Fresenius Medical Care Holdings, Inc. Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal Terminated	KPO	K030497

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