# K062399: Rockwell Medicaltechnologies, Inc. Citrapure

- Pathway: 510(k) (Traditional)
- Applicant: Rockwell Medical Technologies, Inc.
- Decided: Nov 17, 2006 after 93 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 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) Rockwell Medical Technologies Dri-Sate® Acid Concentrate: named in the summary without a submission number
- (no number) Advanced Renal Technologies DRYalysate concentrates for hemodialysis: named in the summary without a submission number

## Most influential descendants
- K130511: Citrisol Acid Concentrate (2014), 5 descendants of its own
- K171750: Citric Complete Dry Citric Acid (45X) (2018), 2 descendants of its own
- K223431: Citric Complete Liquid Citric Acid Concentrate (2023), 1 descendant of its own
- K260799: Nipro Dry Acid Concentrate Mixer (2026), 0 descendants of its own
- K180679: CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate) (2018), 0 descendants of its own

## Indications for use
The Rockwell Medical Technologies CitraPure® Acid Concentrate powders/liquids for bicarbonate dialysate are indicated for use in acute and chronic hemodialysis and are to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.

Source page: https://510kreport.com/device/K062399
Methodology: https://510kreport.com/methodology