Minnifilter Plus Hemofilter and Tubing Set

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Minntech Minnifilter Plus Hemofilter and Tubing Set

510(k) Number

K962707 ↗

FDA Product Code

KDI

Device Class

Class II

Regulation

21 CFR Part 876.5860

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Minntech Corp. →

• What therapeutic procedures can the Minnifilter Plus Hemofilter and Tubing Set be used for in a clinical setting?

  The Minnifilter Plus is designed for artificial kidney therapies, including hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. These procedures are used to treat patients with renal failure, fluid overload, or toxemic conditions by filtering waste products and excess fluids from the blood while preserving essential electrolytes and pH balance.

• Is the Minnifilter Plus Hemofilter and Tubing Set intended for single-use or repeated use, and how should it be handled?

  The Minnifilter Plus is explicitly intended for single-use only, as stated in the device description. It is supplied sterile and requires no additional preparation beyond standard sterile connection protocols in clinical settings like hospitals or dialysis centers. After use, it must be discarded to prevent contamination or reuse.

• What regulatory pathway was followed for FDA clearance of the Minnifilter Plus, and what does that mean for its use?

  The Minnifilter Plus received FDA clearance through a 510(k) submission (K962707), classified as *substantially equivalent* under regulation § 876.5860. This means the device was determined to be as safe and effective as a legally marketed predicate device (a comparable hemodialyzer) and is categorized under product code KDI. The clearance does not imply any specific clinical indication but confirms compliance with FDA requirements for hemodialysis systems.

• Are there multiple sizes or models of the Minnifilter Plus, and how would a buyer determine the correct one for their patient?

  The provided data lists multiple FEI numbers (e.g., 3002806443, 3002807196), which typically correspond to different sizes, configurations, or membrane types of hemodialyzers. While exact specifications (e.g., surface area, blood flow rates) aren’t detailed here, these identifiers suggest the Minnifilter Plus may offer variations to accommodate different patient needs (e.g., pediatric vs. adult). Buyers should consult Minntech Corp. or their distributor for precise sizing guidance based on patient factors like weight, dialysis modality, or clearance requirements.

• How should the Minnifilter Plus Hemofilter and Tubing Set be stored to maintain its sterility and functionality?

  As a sterile, single-use device, the Minnifilter Plus should be stored in its original, unopened packaging in a clean, dry environment protected from direct sunlight, extreme temperatures, or physical damage. The packaging is likely designed to preserve sterility until immediate pre-procedure use. Always follow the manufacturer’s printed instructions for storage conditions, which may include refrigeration or room-temperature storage—details not explicitly stated here but critical for maintaining device integrity.