# K981003: Rockwell Medical Supply, LLC. Dri-Sate Acid Concentrate Mixes

- Pathway: 510(k) (Traditional)
- Applicant: International Medical Products, Inc.
- Decided: Jun 16, 1998 after 90 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.
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. The FDA summary names its predicate without a number.
- (no number) Renal Systems Sta-Pak Bicarbonate Hemodialysis Bath Concentrate Solutions & Powders: named in the summary without a submission number
- (no number) Dial Medical, Inc. Acetate-Based Concentrate: named in the summary without a submission number

## Most influential descendants
- K022500: Dri-Sate Dry Acid Concentrate for Bicarbonate Dialysate (2002), 0 descendants of its own

## Recalls of this device
- Apr 7, 2018 · Class II · Z-1869-2018: A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.
- Dec 3, 2007 · Not classified · Z-0875-2008: 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-0874-2008: Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.

## Indications for use
The Rockwell Medical Supply LLC. Dri-Sate Acid Concentrate Solutions and powders 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/K981003
Methodology: https://510kreport.com/methodology