Asahi AM-R Series Dialyzers

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

510(k) Number

K970650 ↗

FDA Product Code

MSE

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Modified Sepacell Pl-Series Leukocyte Removal Filt

  Class II

  FDA 510(k) K896664 Active Cleared 24 Jan 1990

• Asahi Hollow Fiber Kidneys, Excel

  Class II

  FDA 510(k) K833150 Active Cleared 15 Nov 1983

• Asahi New Pan-Series Hemofilters

  Class II

  FDA 510(k) K844663 Active Cleared 18 Jan 1985

• High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models Aps-R, -M, -S, -E, and -Ex

  Class II

  FDA 510(k) K041726 Active Cleared 23 Jul 2004

• Modified Am-Series Dialyzers

  Class II

  FDA 510(k) K854575 Active Cleared 2 Dec 1985

• APS Series Dialyzers

  Class II

  FDA 510(k) K001250 Active Cleared 16 Aug 2000

See all devices from Asahi Medical Co., Ltd. →

• Are these dialyzers designed for single-use or can they be reused, and if so, how many times?

  The Asahi AM-R Series Dialyzers are supplied as sterile, single-use devices but are specifically designed for reprocessing and reuse on the same patient for up to 15 cycles. This reuse capability is validated through in vitro testing and clinical studies, ensuring safety and efficacy when handled according to the manufacturer’s reprocessing protocols.

• What types of patients are these dialyzers intended for, and what medical condition do they address?

  These dialyzers are intended for patients with chronic or acute renal failure, where they facilitate hemodialysis to remove waste products and excess fluids from the blood. They function by filtering blood through a semipermeable membrane, enabling solute and water exchange with the dialysate.

• How should these dialyzers be stored, and are there any special handling requirements?

  While the AM-R Series is supplied sterile, proper storage and handling are critical for reuse. The manufacturer’s reprocessing protocols must be strictly followed to ensure safety and efficacy across up to 15 cycles. Storage conditions should align with these protocols to maintain sterility and functionality before and after reprocessing.

• What regulatory pathway was followed for this device, and what category does it fall under?

  The Asahi AM-R Series Dialyzers were cleared through the FDA’s 510(k) pathway under Traditional Review, with a decision code of SESE (Substantially Equivalent). They are classified under FDA product code MSE and fall within the Gastroenterology & Urology specialty category, though this is an administrative classification, not an indication.