# K954527: Rockwell Medical Supply LLC Hemodialysis Concentrate Solutions & Powders

- Pathway: 510(k) (Traditional)
- Applicant: Rockwell Medical Supply
- Decided: Mar 1, 1996 after 154 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K131202: Medicalyte (R) Bicarbonate Powder (36.83X), Medicalyte (R) Bicarbonate Powder (45X), Medicalyte (R) Bicarbonate Powder (35X (2014), 4 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
- K260799: Nipro Dry Acid Concentrate Mixer (2026), 0 descendants of its own
- K193155: Nipro Dry Complete Dry Acid Concentrate for Hemodialysis (2020), 0 descendants of its own

## Recalls of this device
- Dec 3, 2007 · Not classified · Z-0872-2008: Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.
- Dec 3, 2007 · Not classified · Z-0871-2008: Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.
- Dec 3, 2007 · Not classified · Z-0873-2008: Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.

Source page: https://510kreport.com/device/K954527
Methodology: https://510kreport.com/methodology