# KPO: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

- Device class: 2; regulation: 21 CFR 876.5820; FDA's rule: 510(k) required
- FDA decisions: 124
- 510(k) review time 2021–2025: median 116 days (middle half 82–265)
- Recalls: 86 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 1
- 2017: 3
- 2018: 2
- 2020: 5
- 2021: 1
- 2022: 2
- 2023: 3
- 2024: 3
- 2025: 2
- 2026: 2

## Most-cited predicates
- K013448: Prismasate (2002), cited by 6
- K910270: Premixed Dialysate for Hemodiafiltration (1991), cited by 5
- K013724: Bicart (2002), cited by 5
- K160847: Rockwell Medical CitraPure Acid Concetrate (2016), cited by 4
- K130511: Citrisol Acid Concentrate (2014), cited by 4
- K864265: Hemodialysis Bath Concentrate Solutions for Hemodi (1987), cited by 4
- K000792: Citrasate Dialysate Acid Concentrate Liquid, Models CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX (2000), cited by 4
- K981043: Dialysol-Acid Concentrate Liquid, Granusol-Acid Concentrate Powder, Renalsol-Acetate Concentrate Liquid & Powder, Biosol (1998), cited by 3
- K980659: Dryalysate Concentrate (1998), cited by 3
- K911459: Granulyte Powder Dialysate Concentrate and Mixing (1991), cited by 3

Source page: https://510kreport.com/product-code/KPO
Data by year (CSV): https://510kreport.com/product-code/KPO.csv