# K131611: Fresenius Dry Acid Dissolution Units

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care North America
- Decided: Aug 29, 2013 after 87 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
No predicates in its family tree.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K191093: Isopure Dry Acid Dissolution System (2020), 1 descendant of its own
- K260799: Nipro Dry Acid Concentrate Mixer (2026), 0 descendants of its own

## Recalls of this device
- Oct 23, 2015 · Class II · Z-0295-2016: Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.
- Oct 23, 2015 · Class II · Z-0296-2016: Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.

## Indications for use
The Fresenius Medical Care Dry Acid Dissolution Unit mixes Fresenius Medical Care distributed dry acid concentrate products with hemodialysis quality water. The resulting liquid acid concentrates are intended for use in three-stream hemodialysis machines calibrated for acid and bicarbonate concentrates.

Source page: https://510kreport.com/device/K131611
Methodology: https://510kreport.com/methodology