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Fresenius Biocarb Hemodialysis Grade Sodium Bicarb

FDA 510(k)

Class II (US FDA 510(k))

510(k) K896111

by Fresenius Usa, Inc.

Identifiers

510(k) Number
K896111 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 Fresenius Biocarb Hemodialysis Grade Sodium Bicarbonate is a Dialysate Concentrate for Hemodialysis (Liquid or Powder). It serves as a key component in hemodialysis solutions, providing sodium bicarbonate to regulate acid-base balance in patients undergoing dialysis for kidney failure. Designed for use in renal replacement therapy, it helps maintain electrolyte homeostasis during treatment.

This product is supplied as a sterile, single-use concentrate intended for preparation of hemodialysis solutions. It is classified under FDA regulation 876.5820 and holds a 510(k) clearance (K896111) for substantial equivalence. Supplied in liquid or powder form, it requires dilution prior to use in dialysis machines. Storage conditions and handling must comply with sterile medical device protocols to ensure safety and efficacy.

Frequently asked questions

What is the primary purpose of the Fresenius Biocarb Hemodialysis Grade Sodium Bicarbonate in dialysis treatment?

This product serves as a dialysate concentrate used to regulate acid-base balance during hemodialysis for patients with kidney failure. By providing sodium bicarbonate, it helps maintain electrolyte homeostasis, which is critical for stabilizing the patient’s pH levels during treatment. It is specifically designed for use in renal replacement therapy.

Is this product intended for direct patient use, or does it require further preparation before use?

The Fresenius Biocarb Hemodialysis Grade Sodium Bicarbonate is supplied as a sterile, single-use concentrate in either liquid or powder form. It must be diluted prior to use in dialysis machines to prepare the final hemodialysis solution. This ensures proper dosing and safety for the patient.

How should this product be stored, and what precautions should be taken given its sterile nature?

Since this is a sterile medical device, storage and handling must follow strict sterile protocols to prevent contamination. While the exact storage conditions aren’t detailed here, standard practices for sterile concentrates—such as keeping it in a clean, dry environment, away from direct sunlight, and ensuring proper sealing—should be followed. Always refer to the manufacturer’s instructions for full guidance.

What forms is this product available in, and does it come in different sizes or models?

The Fresenius Biocarb Hemodialysis Grade Sodium Bicarbonate is available in two forms: liquid or powder. The product code (KPO) and registration numbers indicate it is part of a broader family of dialysate concentrates, but specific sizes or models aren’t detailed in the provided data. For exact formulations or packaging variations, consult the manufacturer’s documentation.

What regulatory pathway was followed for this product’s approval, and how does that affect its use?

This product received FDA 510(k) clearance (K896111) under the substantial equivalence pathway, meaning it was deemed comparable to a legally marketed predicate device. The clearance was granted under FDA regulation 876.5820, which governs dialysate concentrates. Clinicians and buyers can rely on this approval for its safety and performance in hemodialysis settings, though always verify compliance with current FDA guidelines.

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: fresenius biocarb hemodialysis grade sodium bicarb, FDA Browser - Cleared 510 (K) - FRESENIUS BIOCARB HEMODIALYSIS GRADE ..., Fresenius Biocarb Hemodialysis Grade Sodium Bicarb 510 (k) FDA ..., 510(k) K896111 — FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB, FDA Browser - Cleared 510 (K) - FRESENIUS BIOCARB HEMODIALYSIS GRADE ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Fresenius Usa, Inc.

Sources (1)

  • FDA 510(k) K896111 24 fields · synced Sep 20, 2026