Hemodialysis Concentrate, Sodiu

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K781967 ↗

FDA Product Code

KPO

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Renalloy Hemasite Vascular Access Shunt

  Class II

  FDA 510(k) K833622 Active Cleared 29 Nov 1983

• Primus Hollow Fiber Dialyzer (Models 1000, 1000S, 1350, 1350S, 2000, 2000S)

  Class II

  FDA 510(k) K970648 Active Cleared 5 Jan 1998

• Hemasite Graftless Vascular Acess

  Class II

  FDA 510(k) K812890 Active Cleared 16 Nov 1981

• Actril for Kidney Machine Disinfectant

  Class II

  FDA 510(k) K861730 Active Cleared 9 Jun 1987

• Renaflo II

  Class II

  FDA 510(k) K823546 Active Cleared 16 Dec 1982

• Renal Systems Hemodialysis Concentrate

  Class II

  FDA 510(k) K792213 Active Cleared 4 Jan 1980

See all devices from Renal Systems, Inc. →

• What is the primary purpose of this hemodialysis concentrate, and how does it function during treatment?

  This hemodialysis concentrate is designed to be mixed with purified water to create the dialysate solution used in hemodialysis machines. Its role is to regulate electrolytes and maintain the correct pH in the dialysis fluid, which helps remove waste products and excess fluids from a patient’s blood during treatment. It is specifically formulated to support the hemodialysis process by ensuring the dialysate has the proper composition for effective filtration.

• Is this concentrate intended for single-use or can it be reused in multiple hemodialysis sessions?

  The concentrate is explicitly intended for single-use in clinical hemodialysis settings. Since it is a liquid formulation meant to be mixed with purified water for each treatment, reusing it would compromise sterility and safety, which are critical for patient care during hemodialysis.

• What regulatory pathway was followed for this device, and how does that affect its use in clinical settings?

  This hemodialysis concentrate received FDA 510(k) clearance under the classification 876.5820, with the clearance number K781967. The traditional 510(k) pathway confirms it was deemed substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for hemodialysis use. Clinicians can rely on this clearance as evidence of regulatory compliance for its intended purpose in hemodialysis treatment.

• Are there any specific storage instructions provided for this concentrate beyond standard medical device protocols?

  The available data does not specify any unique storage instructions beyond standard medical device protocols. As a liquid concentrate for hemodialysis, it should be stored according to general guidelines for sterile medical liquids—typically in a clean, dry environment, protected from extreme temperatures, and away from direct sunlight. Always follow manufacturer recommendations or facility protocols to ensure integrity until use.