# K171750: Citric Complete Dry Citric Acid (45X)

- Pathway: 510(k) (Traditional)
- Applicant: Dimesol USA, LLC
- Decided: Mar 6, 2018 after 266 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K864265 (1987). 15 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 18 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.
- K131202: Medicalyte (R) Bicarbonate Powder (36.83X), Medicalyte (R) Bicarbonate Powder (45X), Medicalyte (R) Bicarbonate Powder (35X, Dialysis Medical Solutions, LLC (2014) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Aug 5, 2026 · Class II · Z-3135-2026: Hemodialysis concentrates contain high endotoxin levels
- Nov 22, 2024 · Class II · Z-0820-2025: The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.

## Indications for use
This acid concentrate product is formulated for use in acute and chronic hemodialysis and to be used in conjunction with MedicaLyte™ bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as Medicalyte Bicarbonate™, in a 45x three-stream artificial kidney (hemodialysis) machine.

Source page: https://510kreport.com/device/K171750
Methodology: https://510kreport.com/methodology