# K971053: Rockwell Medical Supply,LLC. Bicarbonate Solution Concentrates for Bicarbonate Dialysis

- Pathway: 510(k) (Traditional)
- Applicant: International Medical Products, Inc.
- Decided: Jun 16, 1997 after 84 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K020230: Diasol-Bicarb (2002), 0 descendants of its own

## Indications for use
The Rockwell Medical Supply, LLC Bicarbonate Solution Concentrates for Bicarbonate Dialysis are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine / monitor.

Source page: https://510kreport.com/device/K971053
Methodology: https://510kreport.com/methodology