Modified AM-Series Dialyzers

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

510(k) Number

K892375 ↗

FDA Product Code

FJI

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 AM-R Series Dialyzers

  Class II

  FDA 510(k) K970650 Active Cleared 30 Sep 1997

• 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

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

• Are the Modified AM-Series Dialyzers reusable or intended for single-use only?

  The Modified AM-Series Dialyzers are explicitly designed for single-use only. As a sterile medical device, they must not be reused or reprocessed to maintain patient safety and prevent contamination, adhering to standard sterile medical device protocols.

• What clinical settings or environments are these dialyzers approved for?

  These dialyzers are intended for use in clinical hemodialysis settings, including dedicated hemodialysis units. They are regulated under FDA 510(k) clearance (K892375) as Class II devices, meaning they must be used in controlled medical environments where sterile procedures are followed.

• What sizes or models are available for the Modified AM-Series Dialyzers?

  The provided data does not specify exact sizes or model numbers, but the Modified AM-Series Dialyzers are capillary, hollow-fiber dialyzers with multiple registration numbers (e.g., 2028411, 1721676) under FDA’s OpenFDA database. For precise sizing or model details, refer to Asahi Medical’s official product catalog or technical documentation.

• How should these dialyzers be stored before use?

  As sterile single-use devices, the Modified AM-Series Dialyzers should be stored in their original, unopened packaging in a clean, dry environment protected from extreme temperatures and direct sunlight. Follow manufacturer guidelines for shelf-life and storage conditions to ensure sterility and functionality.

• What is the regulatory pathway for these dialyzers, and how was the FDA clearance determined?

  The Modified AM-Series Dialyzers were cleared via a traditional 510(k) pathway (K892375) and are classified as substantially equivalent (SESE) to a predicate device. The clearance was reviewed by the FDA’s Gastroenterology and Urology (GU) Advisory Committee in 1989, with a decision date of May 18, 1989, under product code FJI for hemodialysis devices.