# K022500: Dri-Sate Dry Acid Concentrate for Bicarbonate Dialysate

- Pathway: 510(k) (Traditional)
- Applicant: Rockwell Medical Technologies, Inc.
- Decided: Dec 23, 2002 after 147 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
Longest line of descent: 1 generation back to K911459 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981003: Rockwell Medical Supply, LLC. Dri-Sate Acid Concentrate Mixes, International Medical Products, Inc. (1998) Summary page 2.
- K911459: Granulyte Powder Dialysate Concentrate and Mixing, Fresenius USA, Inc. (1991) Summary page 2.

## Indications for use
The Rockwell Medical Technologies, Inc., Dri-Sate Dry Acid Concentrates for Bicarbonate Dialysate 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/K022500
Methodology: https://510kreport.com/methodology