HPR Home Patient Renatron

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K833181 ↗

FDA Product Code

LIF

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• 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

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• Actril for Kidney Machine Disinfectant

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• Renaflo II

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  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 HPR Home Patient Renatron used for?

  The HPR Home Patient Renatron is designed specifically for cleaning, disinfecting, and storing hemodialysis dialyzers in home-based patient care settings. It automates the reprocessing cycle to ensure dialyzers meet clinical standards for reuse, which is critical for patients undergoing long-term dialysis. This reduces waste and lowers costs by enabling the safe reuse of single-use dialyzers under controlled conditions.

• How is the HPR Home Patient Renatron supplied and intended for use?

  The system is supplied as a standalone reprocessing unit, meaning it does not require additional components beyond what is included in the package. It is intended for single-patient use per cycle, meaning each cycle reprocesses dialyzers for one patient only. The device operates in non-sterile environments but maintains controlled conditions to ensure sterility during reprocessing, allowing for safe reuse of dialyzers.

• Is the HPR Home Patient Renatron sterile or non-sterile?

  The reprocessing system itself operates in a non-sterile environment, but it is engineered to process dialyzers under controlled conditions that ensure sterility for reuse. The device follows protocols to maintain clinical-grade sterility during the cleaning, disinfection, and storage phases of the cycle, making it suitable for single-patient reuse.

• Can the HPR Home Patient Renatron reprocess dialyzers for multiple patients?

  No, the HPR Home Patient Renatron is designed for single-patient use per cycle. Each reprocessing cycle is intended to clean and disinfect dialyzers exclusively for one patient, ensuring compliance with clinical standards for sterility and safety. This prevents cross-contamination and maintains the integrity of the dialysis treatment.

• What storage and maintenance guidelines should be followed for the HPR Home Patient Renatron?

  Storage and maintenance of the HPR Home Patient Renatron must adhere to the manufacturer’s published guidelines to ensure proper functionality and compliance with reprocessing protocols. This includes regular cleaning of the unit’s exterior surfaces, proper storage in a dry, clean environment, and adherence to the automated cycle parameters to maintain sterility. Failure to follow these guidelines could compromise the device’s performance or the sterility of reprocessed dialyzers.