# K171015: Citryte

- Pathway: 510(k) (Traditional)
- Applicant: Di-Chem, Inc.
- Decided: Oct 13, 2017 after 192 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). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160847: Rockwell Medical CitraPure Acid Concetrate, Rockwell Medical (2016) Summary page 4.
- K130511: Citrisol Acid Concentrate, Diasol, Inc. (2014) Summary page 4.
- K980659: Dryalysate Concentrate, Advanced Renal Technologies, Inc. (1998) Summary page 4.

## Indications for use
The Di-Chem, Inc. Citryte Acid Concentrate for bicarbonate dialysis is indicated for use in the treatment of acute and chronic hemodialysis. It is to be used with the appropriate hemodialysis machine and sodium bicarbonate concentrate.

Source page: https://510kreport.com/device/K171015
Methodology: https://510kreport.com/methodology