# K991512: Asahi AM-R-Series Dialyzers (Modified), Model AM-NR-X

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Medical Co., Ltd.
- Decided: Jul 29, 1999 after 90 days
- Product code: FJI (Dialyzer, Capillary, Hollow Fiber)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K892374 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970650: Asahi AM-R Series Dialyzers, Asahi Medical Co., Ltd. (1997) Summary page 1.

## Recalls of this device
- Oct 12, 2006 · Not classified · Z-0175-2007: There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle.

## Indications for use
The AM-R Series Dialyzers are indicated for use in hemodialysis treatment of patients who have chronic renal failure or acute renal failure. Asahi AM-R Dialyzers may be reprocessed for reuse on the same patient.

Source page: https://510kreport.com/device/K991512
Methodology: https://510kreport.com/methodology