Ultramax Dialyzer Reprocessing System

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

Full name

Ultramax

510(k) Number

K832705 ↗

FDA Product Code

LIF

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Medicorp Dehydracon a Dehydrated Dialysate Concent

  Class II

  FDA 510(k) K844850 Active Cleared 2 Apr 1985

• Ultramax III, Dialyzer Reprocessing Device

  Class II

  FDA 510(k) K860026 Active Cleared 14 Mar 1986

• Negatove Pressure Convertor

  Class II

  FDA 510(k) K791164 Active Cleared 4 Oct 1979

• Medi-Trak Portable Traction Device

  Class I

  FDA 510(k) K791396 Active Cleared 16 Aug 1979

• What is the Ultramax Dialyzer Reprocessing System used for?

  The Ultramax Dialyzer Reprocessing System is designed specifically for the automated cleaning, disinfection, and reuse of hemodialysis dialyzers. It streamlines the reprocessing cycle to meet clinical standards for patient safety, helping dialysis facilities minimize waste and operational expenses while adhering to regulatory requirements for blood-contacting medical devices.

• How is the Ultramax Dialyzer Reprocessing System supplied, and where is it intended for use?

  The system is supplied as a complete reprocessing unit, intended exclusively for use in sterile or semi-sterile dialysis centers under controlled conditions. It is not intended for home use or non-clinical environments. The controlled environment ensures proper handling and adherence to reprocessing protocols.

• Is the Ultramax Dialyzer Reprocessing System single-use or reusable?

  The Ultramax Dialyzer Reprocessing System is designed for single-use per reprocessing cycle. However, the system itself can be reused for multiple dialyzer reprocessing sessions, provided the manufacturer’s instructions are strictly followed to maintain safety and efficacy. This allows facilities to maximize cost efficiency while ensuring compliance.

• What regulatory classification does the Ultramax Dialyzer Reprocessing System hold, and what does this mean for its use?

  The Ultramax Dialyzer Reprocessing System is classified as a Class II medical device under FDA regulations (21 CFR 876.5820). This classification indicates that it is subject to special controls to ensure its safety and effectiveness, including validated reprocessing protocols to minimize contamination risks during reuse. Facilities must follow these guidelines to maintain compliance and patient safety.

• Does the Ultramax Dialyzer Reprocessing System require any special storage conditions?

  While the provided data does not specify explicit storage conditions, the system is intended for use in controlled dialysis center environments. Proper storage should follow manufacturer guidelines to preserve functionality, prevent contamination, and ensure the system remains ready for use when needed. Always refer to the included instructions for detailed storage recommendations.