# K130511: Citrisol Acid Concentrate

- Pathway: 510(k) (Traditional)
- Applicant: Diasol, Inc.
- Decided: Feb 10, 2014 after 348 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: 1 generation back to K854391 (1986). 4 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K854391: Hemodialysis Concentrate, Dana Laboratories (1986) Summary page 1.
- K993212: Dryasol Acid Concentrate Mix, Diasol, Inc. (1999) Summary page 1.
- K062399: Rockwell Medicaltechnologies, Inc. Citrapure, Rockwell Medical Technologies, Inc. (2006) Summary page 1.
- K000792: Citrasate Dialysate Acid Concentrate Liquid, Models CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX, Advanced Renal Technologies, Inc. (2000) Summary page 1.

## 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
CitriSol acid concentrate dry powder or liquid is indicated for use in the acute and chronic Hemodialysis. It is an accessory to be used with the appropriate Hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO standard water for hemodialysis and Sodium Bicarbonate Mix.

Source page: https://510kreport.com/device/K130511
Methodology: https://510kreport.com/methodology