# K212620: Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: May 12, 2022 after 267 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 K981043 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192017: Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate, Fresenius Medical Care Renal Therapies Group, LLC (2020) Summary page 4.

## 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

## 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/K212620
Methodology: https://510kreport.com/methodology