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SolCart B Dialysate Concentrate for Hemodialysis

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K102194

by B.Braun Avitum AG

Identifiers

510(k) Number
K102194 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)

The SolCart B is a Dialysate Concentrate for Hemodialysis (Liquid or Powder), classified as a Class II medical device under FDA regulations. It is designed to be mixed with water to produce hemodialysis fluid, facilitating the removal of waste products and excess fluids from the blood during renal replacement therapy. The concentrate ensures precise electrolyte balance and pH control to support safe and effective dialysis procedures.

Supplied as a sterile, single-use powder or liquid concentrate, the SolCart B is intended for use in hemodialysis machines within clinical settings such as hospitals, dialysis centers, and outpatient care facilities. It adheres to FDA 510(k) clearance (K102194) and EU MDR compliance, with regulatory oversight under the Dialysate Concentrate for Hemodialysis product code (KPO). Storage and handling must comply with manufacturer guidelines to maintain sterility and efficacy, ensuring proper preparation for hemodialysis sessions.

Frequently asked questions

What types of hemodialysis settings can the SolCart B be used in, and why is this important for clinical operations?

The SolCart B is designed for use in hemodialysis machines within clinical settings such as hospitals, dialysis centers, and outpatient care facilities. This versatility is important because it ensures compatibility with standard dialysis infrastructure, allowing for seamless integration into existing workflows. Its sterile, single-use formulation also minimizes contamination risks, which is critical for maintaining patient safety during renal replacement therapy.

Is the SolCart B available in both liquid and powder forms, and how does this affect its handling and storage?

Yes, the SolCart B is supplied as a sterile, single-use concentrate in either liquid or powder form. The powder format may offer advantages in stability and shelf life, while the liquid form could simplify preparation for facilities with limited mixing capabilities. Both forms require adherence to manufacturer guidelines for storage to preserve sterility and efficacy, ensuring proper handling before use in hemodialysis sessions.

How does the SolCart B ensure precise electrolyte balance and pH control during hemodialysis, and why is this critical for patient outcomes?

The SolCart B is formulated to provide precise electrolyte balance and pH control when mixed with water to create hemodialysis fluid. This is critical because maintaining stable electrolyte levels and pH during dialysis prevents complications like metabolic disturbances, muscle cramps, or cardiovascular strain. The concentrate’s design supports safe and effective removal of waste products and excess fluids, directly impacting patient safety and treatment efficacy.

What regulatory pathways does the SolCart B follow, and how does this affect its availability in different markets?

The SolCart B follows FDA 510(k) clearance (K102194) and EU MDR compliance, ensuring it meets stringent regulatory standards in the U.S. and European markets. This dual regulatory approval allows for broader availability, enabling healthcare providers in both regions to rely on its safety and performance for hemodialysis procedures. The device’s classification as Class II under FDA regulations further underscores its rigorous oversight.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
B.Braun Avitum AG
FDA Applicant
B. Braun Avitum AG

Sources (2)

  • FDA 510(k) K102194 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026