# K911459: Granulyte Powder Dialysate Concentrate and Mixing

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius USA, Inc.
- Decided: Jul 17, 1991 after 105 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.
10 later devices descend from it; 3 cite it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K980659: Dryalysate Concentrate (1998), 7 descendants of its own
- K160847: Rockwell Medical CitraPure Acid Concetrate (2016), 5 descendants of its own
- K171750: Citric Complete Dry Citric Acid (45X) (2018), 2 descendants of its own
- K223431: Citric Complete Liquid Citric Acid Concentrate (2023), 1 descendant of its own
- K030497: Fresenius Naturalyte Granuflo Dry Acid Concentrate 10XX Series, 24XX Series, 30XX Series (2003), 1 descendant of its own

## Recalls of this device
- Oct 23, 2015 · Class II · Z-0294-2016: 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.
- Nov 20, 2009 · Not classified · Z-2226-2010: Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.

Source page: https://510kreport.com/device/K911459
Methodology: https://510kreport.com/methodology