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Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate

FDA 510(k)

Class II (US FDA 510(k))

510(k) K212620

by Fresenius Medical Care Renal Therapies Group, LLC

Identifiers

510(k) Number
K212620 FDA 510(k)
FDA Product Code
KPO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5820 FDA 510(k)
Regulation Number
876.5820 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Dialysate Concentrate for Hemodialysis (Liquid), classified as a Class II medical device under FDA regulation 876.5820. It serves as a concentrated acid component used in the preparation of bicarbonate-based hemodialysis solutions. Citrasate contains citric acid, while NaturaLyte offers multiple formulations, both designed to adjust dialysate pH for extracorporeal bicarbonate hemodialysis in patients with acute or chronic renal failure.

The concentrate is supplied as a liquid in sterile, single-use containers (cases or drums) and must be diluted with water and other components to prepare dialysate. It is intended for use in hemodialysis machines and is regulated under FDA 510(k) clearance (K212620) with a traditional review pathway. No MRI safety or reusable design information is specified; sterility is maintained via aseptic processing for single-use applications. Storage and handling follow standard sterile liquid medical device protocols.

Frequently asked questions

What is the primary purpose of Citrasate and NaturaLyte Liquid Acid Concentrate in hemodialysis treatment?

Citrasate and NaturaLyte Liquid Acid Concentrate are concentrated acid components used to prepare bicarbonate-based hemodialysis solutions. They adjust the dialysate pH, which is essential for extracorporeal bicarbonate hemodialysis in patients with acute or chronic renal failure. The concentrates are designed to be mixed with water and other components to create the final dialysate solution used in hemodialysis machines.

How is this product supplied, and is it intended for single-use or reuse?

Citrasate and NaturaLyte Liquid Acid Concentrate are supplied as sterile, single-use liquid containers, packaged in cases or drums. The product is not designed for reuse, and sterility is maintained through aseptic processing for single-use applications only. This ensures safety and compliance with sterile medical device protocols.

What storage and handling requirements apply to these concentrates?

Since Citrasate and NaturaLyte are sterile liquid medical devices, they must be stored and handled according to standard sterile liquid medical device protocols. While specific storage conditions (e.g., temperature, humidity) are not detailed in the data, general practices for sterile liquids—such as protection from contamination, proper labeling, and adherence to manufacturer guidelines—should be followed to maintain integrity until use.

Are there different formulations available for NaturaLyte, and how does that differ from Citrasate?

NaturaLyte offers multiple formulations, whereas Citrasate contains citric acid as its primary acid component. The variations in NaturaLyte formulations are designed to provide flexibility in adjusting dialysate pH for hemodialysis, catering to different patient needs or treatment protocols. Citrasate, in contrast, relies solely on citric acid for pH adjustment, making it a more standardized option.

What regulatory pathway was followed for FDA clearance of this device, and what does that mean for buyers?

Citrasate and NaturaLyte Liquid Acid Concentrate were cleared through the FDA’s 510(k) traditional review pathway (K212620) under classification 876.5820 as a Class II device. This means the manufacturer demonstrated that the device is substantially equivalent to a legally marketed predicate device, ensuring compliance with FDA standards for safety and effectiveness. Buyers can rely on this clearance as evidence of regulatory scrutiny before market introduction.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NaturaLyte Liquid Acid Concentrate - FMCNA, Citrasate Liquid Acid Concentrate - FMCNA, Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Fresenius Medical Care Renal Therapies Group, LLC

Sources (1)

  • FDA 510(k) K212620 24 fields · synced Sep 20, 2026