# K260799: Nipro Dry Acid Concentrate Mixer

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Technical Solutions, Incoporated
- Decided: Aug 19, 2026 after 161 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: 5 generations back to K864265 (1987). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983618: Dri-Sate Mixer for Preparation of Acidified Dialysate Concentrate, Rockwell Medical Technologies, Inc. (1999) Summary page 5.
- K191093: Isopure Dry Acid Dissolution System, Isopure, Corp. (2020) Summary page 5.
- K223431: Citric Complete Liquid Citric Acid Concentrate, Nipro Renal Solutions USA, Corp. (2023) Summary page 5.

## Indications for use
The Nipro Dry Acid Concentrate Mixer is intended for the mixing of dry acid concentrate with treated water that meets the requirements of ISO 23500-3, “Preparation and quality management of fluids for hemodialysis and related therapies—Part 3: Water for hemodialysis and related therapies” to produce an acid concentrate solution intended for use in hemodialysis treatment and related therapies, using a 3-stream dialysate (acid concentrate, bicarbonate concentrate, and water).

Source page: https://510kreport.com/device/K260799
Methodology: https://510kreport.com/methodology