Device type
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Product code KPO · Class II · 21 CFR 876.5820 · Gastroenterology, Urology
Recent 510(k)s
Aug 19, 2026
K260799
Nipro Dry Acid Concentrate Mixer
Nipro Technical Solutions, Incoporated
- KPO
- Class II
Recent recalls
Sep 16, 2026
Z-3135-2026
Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
Nipro Renal Soultions USA, Corporation
- KPO
- Class II
- Ongoing
Sep 16, 2026
Z-3133-2026
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Nipro Renal Soultions USA, Corporation
- KPO
- Class II
- Ongoing
Sep 16, 2026
Z-3136-2026
Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
Nipro Renal Soultions USA, Corporation
- KPO
- Class II
- Ongoing
Sep 16, 2026
Z-3134-2026
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
Nipro Renal Soultions USA, Corporation
- KPO
- Class II
- Ongoing
Sep 9, 2026
Z-3092-2026
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,…
Fresenius Medical Care Renal Therapies Group, LLC
- KPO
- Class II
- Ongoing
Sep 9, 2026
Z-3093-2026
Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate H…
Fresenius Medical Care Renal Therapies Group, LLC
- KPO
- Class II
- Ongoing
Sep 9, 2026
Z-3091-2026
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
Fresenius Medical Care Renal Therapies Group, LLC
- KPO
- Class II
- Ongoing