# K223431: Citric Complete Liquid Citric Acid Concentrate

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Renal Solutions USA, Corp.
- Decided: Aug 4, 2023 after 263 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K864265 (1987). 16 ancestors in all.
1 later device descends 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.
- K901471: GC-1000 Through GC-3005 Acid Concentrate, Granite Chemical Co., Inc. (1990) Summary page 4.
- K171750: Citric Complete Dry Citric Acid (45X), Dimesol USA, LLC (2018) Summary page 4.

## Most influential descendants
- K260799: Nipro Dry Acid Concentrate Mixer (2026), 0 descendants of its own

## Recalls of this device
- Aug 5, 2026 · Class II · Z-3136-2026: Hemodialysis concentrates contain high endotoxin levels

## Indications for use
For LC+100 Series: This acid concentrate is formulated for use in acute and chronic hemodialysis, and is to be used in conjunction with Nipro MedicaLyte bicarbonate concentrate, or an equivalent bicarbonate concentrate of the same composition, in a 36.83X proportioning three-stream hemodialysis machine. For LC+200 Series: This acid concentrate is formulated for use in acute and chronic hemodialysis, and is to be used in conjunction with Nipro MedicaLyte bicarbonate concentrate, or an equivalent bicarbonate concentrate of the same composition, in a 45X proportioning three-stream hemodialysis machine.

Source page: https://510kreport.com/device/K223431
Methodology: https://510kreport.com/methodology