AF-150 Hemodialyzer

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

510(k) Number

K992566 ↗

FDA Product Code

KDI

Device Class

Class II

Regulation

21 CFR Part 876.5860

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Af-220 Hemodialyzer

  Class II

  FDA 510(k) K992573 Active Cleared 18 Jan 2000

• A-15 Hemodialyzer

  Class II

  FDA 510(k) K992594 Active Cleared 24 Sep 1999

• A-22 Hemodialyzer

  Class II

  FDA 510(k) K992563 Active Cleared 18 Jan 2000

• Althin Medical Ab Altracart II

  Class II

  FDA 510(k) K990010 Active Cleared 15 Apr 1999

• Af-180 Hemodialyzer

  Class II

  FDA 510(k) K992564 Active Cleared 18 Jan 2000

• A-18 Hemodialyzer

  Class II

  FDA 510(k) K992565 Active Cleared 23 Sep 1999

• What clinical setting is the AF-150 Hemodialyzer intended for, and why is it designed as single-use?

  The AF-150 Hemodialyzer is designed exclusively for clinical settings like hospitals and dialysis centers, where hemodialysis procedures are performed. It is intended for single-use to ensure patient safety by eliminating the risk of cross-contamination between patients, which is critical in renal failure treatment where sterility and reliability are paramount.

• How is the AF-150 Hemodialyzer supplied, and what does 'sterile for immediate clinical use' mean in this context?

  The AF-150 Hemodialyzer is supplied sterile and ready for immediate clinical use, meaning it undergoes terminal sterilization to ensure no microbial contamination remains before packaging. This allows clinicians to open and use it directly without additional sterilization steps, reducing procedural time and ensuring consistency in patient care.

• What regulatory pathway was followed for FDA clearance of the AF-150 Hemodialyzer, and what does 'substantially equivalent' indicate?

  The AF-150 Hemodialyzer followed the FDA 510(k) pathway, specifically a traditional review process, to demonstrate it is 'substantially equivalent' to a legally marketed predicate device. This means it has the same intended use and technological characteristics as the predicate, meeting FDA’s criteria for safety and effectiveness under 21 CFR §876.5860 without requiring a full premarket approval.

• Are there different sizes or models of the AF-150 Hemodialyzer, and how would a clinician determine the appropriate one for a patient?

  The provided data does not specify distinct sizes or models beyond the AF-150 designation, but the device is categorized under high-permeability hemodialyzers, which typically vary by membrane surface area, blood flow rate compatibility, and clearance rates. Clinicians would select the appropriate model based on patient-specific factors like body size, dialysis prescription (e.g., Kt/V targets), and comorbidities, often guided by manufacturer guidelines or nephrology protocols.