# K192017: Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: Apr 24, 2020 after 270 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981043 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000792: Citrasate Dialysate Acid Concentrate Liquid, Models CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX, Advanced Renal Technologies, Inc. (2000) Summary page 4.
- K981043: Dialysol-Acid Concentrate Liquid, Granusol-Acid Concentrate Powder, Renalsol-Acetate Concentrate Liquid & Powder, Biosol, Solution Technologies (1998) Summary page 4.

## Most influential descendants
- K212620: Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate (2022), 0 descendants of its own

## Recalls of this device
- Jul 14, 2026 · Class II · Z-3093-2026: Complaints of blue-green discoloration in product
- Jul 14, 2026 · Class II · Z-3092-2026: Complaints of blue-green discoloration in product
- Jun 1, 2022 · Class II · Z-1311-2022: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of pot
- May 31, 2022 · Class II · Z-1371-2022: Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use
- May 31, 2022 · Class II · Z-1370-2022: Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use
- Apr 28, 2021 · Class II · Z-2086-2021: Exposed to freezing temperatures due to refrigerated truck malfunctions

## Indications for use
Citrasate® Liquid Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. Citrasate® Liquid 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. NaturaLyte® Liquid Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. NaturaLyte® Liquid 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/K192017
Methodology: https://510kreport.com/methodology