# K023985: Acidified Component Concentrates for Bicarbonate Dialysis Containing DI-Acetate

- Pathway: 510(k) (Traditional)
- Applicant: Rockwell Medical Technologies, Inc.
- Decided: Feb 28, 2003 after 88 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
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 Dri-Sate Acid Concentrate Solutions and Powders: named in the summary without a submission number
- (no number) Fresenius USA, Inc. Granuflo Dialysate Concentrate: named in the summary without a submission number

## Indications for use
The Rockwell Medical Technologies, Inc., Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor and bicarbonate concentrate

Source page: https://510kreport.com/device/K023985
Methodology: https://510kreport.com/methodology