# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Global Scientific Technologies, LLC
- Decided: Dec 7, 2018 after 267 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: 3 generations back to K864265 (1987). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982378: Hemsol-Acid Concentrate Liquid Hemogran Acid Concentrate Powder, Nephrosol-Acetate Concentrate Powder, Bicarbosol-Bicare, Solution Technologies (1998) Summary page 8.
- K160847: Rockwell Medical CitraPure Acid Concetrate, Rockwell Medical (2016) Summary page 8.
- K062399: Rockwell Medicaltechnologies, Inc. Citrapure, Rockwell Medical Technologies, Inc. (2006) Summary page 8.
- K000792: Citrasate Dialysate Acid Concentrate Liquid, Models CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX, Advanced Renal Technologies, Inc. (2000) Summary page 8.
- K130511: Citrisol Acid Concentrate, Diasol, Inc. (2014) Summary page 8.

## Indications for use
AcetiCon acid concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with bicarbonate concentrate. CitriCon acid concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with bicarbonate concentrate. BicarboCon bicarbonate concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with acid concentrate. RenaCon acetate concentrate liquids or powders for acetate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 2 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis.

Source page: https://510kreport.com/device/K180679
Methodology: https://510kreport.com/methodology