# K160847: Rockwell Medical CitraPure Acid Concetrate

- Pathway: 510(k) (Traditional)
- Applicant: Rockwell Medical
- Decided: Oct 20, 2016 after 206 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K864265 (1987). 6 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980659: Dryalysate Concentrate, Advanced Renal Technologies, Inc. (1998) Summary page 4.
- K000792: Citrasate Dialysate Acid Concentrate Liquid, Models CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX, Advanced Renal Technologies, Inc. (2000) Summary page 4.

## Most influential descendants
- K171750: Citric Complete Dry Citric Acid (45X) (2018), 2 descendants of its own
- K223431: Citric Complete Liquid Citric Acid Concentrate (2023), 1 descendant of its own
- K260799: Nipro Dry Acid Concentrate Mixer (2026), 0 descendants of its own
- K180679: CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate) (2018), 0 descendants of its own
- K171015: Citryte (2017), 0 descendants of its own

## Indications for use
The Rockwell Medical CitraPure® Acid Concentrates powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.

Source page: https://510kreport.com/device/K160847
Methodology: https://510kreport.com/methodology