# K022521: Bicarbonate Dialysate Concentrate Mixer, Model 50 Gallon & 100 Gallon

- Pathway: 510(k) (Traditional)
- Applicant: Rockwell Medical Technologies, Inc.
- Decided: Jan 3, 2003 after 157 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Rockwell Medical Technologies Dri-Sate Mixer for Dri-Sate acid concentrate solutions: named in the summary without a submission number
- (no number) Fresenius USA, Inc. Hemodialysis Concentration Dissolution Unit P/N 89-290-09: named in the summary without a submission number

## Recalls of this device
- Sep 29, 2008 · Not classified · Z-0440-2009: Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed.
- Sep 29, 2008 · Not classified · Z-0439-2009: Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed.

## Indications for use
The Rockwell Medical Technologies' Bicarbonate Dialysate Concentrate Mixer is designed to mix the Rockwell Medical Technologies Concentrate Powders for Bicarbonate Dialysis with purified water to produce a bicarbonate concentrate solutions for hemodialysis for use in 3- stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines / monitors. The Rockwell Medical Technologies, Inc Concentrate Powders for Bicarbonate Dialysis which are mixed with water in the Bicarbonate Dialysate Concentrate Mixer are indicated for use in acute and chronic hemodialysis.

Source page: https://510kreport.com/device/K022521
Methodology: https://510kreport.com/methodology