# K892375: Modified AM-Series Dialyzers

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Medical Co., Ltd.
- Decided: May 18, 1989 after 48 days
- Product code: FJI (Dialyzer, Capillary, Hollow Fiber)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K970650: Asahi AM-R Series Dialyzers (1997), 1 descendant of its own
- K991512: Asahi AM-R-Series Dialyzers (Modified), Model AM-NR-X (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K892375
Methodology: https://510kreport.com/methodology