# K191093: Isopure Dry Acid Dissolution System

- Pathway: 510(k) (Traditional)
- Applicant: Isopure, Corp.
- Decided: Jan 22, 2020 after 272 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 K131611 (2013). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131611: Fresenius Dry Acid Dissolution Units, Fresenius Medical Care North America (2013) Summary page 4.

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

## Indications for use
The Isopure Corp Dry Acid Dissolution System is designed to mix dry acid concentrates with purified water to produce an acid concentrate solution for hemodialysis for use in 3- Stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines.

Source page: https://510kreport.com/device/K191093
Methodology: https://510kreport.com/methodology