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Panels › Gastroenterology, Urology › Product code KPO · Class 2

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

Company510(k)sRecalls
Fresenius Medical Care Holdings, Inc.059
Fresenius Medical Care Renal Therapies Group, LLC1012
Nxstage Medical, Inc.615
Diasol, Inc.48
Rockwell Medical Technologies, Inc.57
Baxter Healthcare Corp71
Gambro Renal Products60
Nipro Renal Soultions USA, Corporation06
Di-Chem, Inc.50
Isopure, Corp.23
DateFirm and productCodeLinked 510(k)
Sep 10, 2026Nipro Renal Soultions USA, Corporation
Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
Open, Classified		 KPOK223431
Sep 10, 2026Nipro Renal Soultions USA, Corporation
Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
Open, Classified		 KPOK171750
Sep 10, 2026Nipro Renal Soultions USA, Corporation
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
Open, Classified		 KPOK131202
Sep 10, 2026Nipro Renal Soultions USA, Corporation
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Open, Classified		 KPOK012547
Sep 3, 2026Fresenius Medical Care Renal Therapies Group, LLC
Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis
Open, Classified		 KPOK192017
K212620
Sep 3, 2026Fresenius Medical Care Renal Therapies Group, LLC
NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for
Open, Classified		 KPOK192017
K212620
Sep 3, 2026Fresenius Medical Care Renal Therapies Group, LLC
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
Open, Classified		 KPOK192209
Jun 11, 2026Fresenius Medical Care Holdings, Inc.
Bicarby Dialysate; Model number: RFP-400-G;
Open, Classified		 KPOK243786
Jun 5, 2026Fresenius Medical Care Holdings, Inc.
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
Open, Classified		 KPOK233950
K243786
Dec 23, 2025Diasol, Inc
Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Open, Classified		 KPOK851431
Dec 23, 2025Diasol, Inc
Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Open, Classified		 KPOK851431
Dec 23, 2025Diasol, Inc
Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Open, Classified		 KPOK851431
Dec 23, 2025Diasol, Inc
Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Open, Classified		 KPOK851431
Dec 23, 2025Diasol, Inc
Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Open, Classified		 KPOK851431
Dec 23, 2025Diasol, Inc
Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Open, Classified		 KPOK851431
May 28, 2025NxStage Medical Inc
NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
Open, Classified		 KPOK053286
May 14, 2025Nipro Renal Soultions USA, Corporation
MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).
Open, Classified		 KPOK012547
Jan 8, 2025Nipro Renal Soultions USA, Corporation
Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
Open, Classified		 KPOK171750
Oct 23, 2024Diasol, Inc
Diasol Acid Concentrate REF G100325-10Dex 100
Open, Classified		 KPOK851431
Jun 20, 2024NxStage Medical Inc
NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456
Open, Classified		 KPOK053286
Nov 4, 2022Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
Open, Classified		 KPOK070177
Sep 13, 2022Isopure Corp
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and
Terminated		 KPOK120005
Jun 1, 2022Fresenius Medical Care Holdings, Inc.
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Terminated		 KPOK192017
May 31, 2022Fresenius Medical Care Holdings, Inc.
NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2
Open, Classified		 KPOK192017
May 31, 2022Fresenius Medical Care Holdings, Inc.
NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-2251-0
Open, Classified		 KPOK192017
Apr 28, 2021Fresenius Medical Care Holdings, Inc.
NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according
Terminated		 KPOK191474
Apr 28, 2021Fresenius Medical Care Holdings, Inc.
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine
Terminated		 KPOK192017
Apr 28, 2021Fresenius Medical Care Holdings, Inc.
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine accordin
Terminated		 KPOK192209
Apr 28, 2021Fresenius Medical Care Holdings, Inc.
(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end stage renal disease going under PD in healthcare or home sett
Terminated		 KPOK162716
Jan 11, 2021Fresenius Medical Care Holdings, Inc.
Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution thr
Open, Classified		 KPOK070177
Jan 11, 2021Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution thre
Open, Classified		 KPOK070177
Jan 11, 2021Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution thre
Open, Classified		 KPOK070177
Jan 11, 2021Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th
Open, Classified		 KPOK070177
Jan 11, 2021Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th
Open, Classified		 KPOK070177
Jan 11, 2021Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th
Open, Classified		 KPOK070177
Jan 11, 2021Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th
Open, Classified		 KPOK070177
Jan 11, 2021Fresenius Medical Care Holdings, Inc.
Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th
Open, Classified		 KPOK070177
Jan 11, 2021Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th
Open, Classified		 KPOK070177
Jan 11, 2021Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th
Open, Classified		 KPOK070177
Jan 11, 2021Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th
Open, Classified		 KPOK070177
Jan 11, 2021Fresenius Medical Care Holdings, Inc.
Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution thre
Open, Classified		 KPOK070177
Jan 11, 2021Fresenius Medical Care Holdings, Inc.
Citrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution thre
Open, Classified		 KPOK070177
Jan 11, 2021Fresenius Medical Care Holdings, Inc.
Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th
Open, Classified		 KPOK070177
Jan 11, 2021Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution thre
Open, Classified		 KPOK070177
Jan 11, 2021Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution thre
Open, Classified		 KPOK070177
Jan 11, 2021Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution thre
Open, Classified		 KPOK070177
Jan 11, 2021Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution thre
Open, Classified		 KPOK070177
Jan 11, 2021Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th
Open, Classified		 KPOK070177
Jan 11, 2021Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th
Open, Classified		 KPOK070177
Jan 11, 2021Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th
Open, Classified		 KPOK070177

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