# K192209: Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: May 8, 2020 after 268 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K864265 (1987). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980659: Dryalysate Concentrate, Advanced Renal Technologies, Inc. (1998) Summary page 4.
- K030497: Fresenius Naturalyte Granuflo Dry Acid Concentrate 10XX Series, 24XX Series, 30XX Series, Fresenius Medical Care (2003) Summary page 4.

## Recalls of this device
- Jul 14, 2026 · Class II · Z-3091-2026: Complaints of blue-green discoloration in product
- Apr 28, 2021 · Class II · Z-2084-2021: Exposed to freezing temperatures due to refrigerated truck malfunctions

## Indications for use
Citrasate® Dry Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. Citrasate® Dry Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician’s prescription. GranuFlo® Dry Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. GranuFlo® Dry Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician’s prescription.

Source page: https://510kreport.com/device/K192209
Methodology: https://510kreport.com/methodology