# K001250: Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models)

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Medical Co., Ltd.
- Decided: Aug 16, 2000 after 119 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
31 later devices descend from it; 8 cite it directly.
0 of 32 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
- K041726: High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models Aps-R, -M, -S, -E, and -EX (2004), 22 descendants of its own
- K051187: Rexeed Series Dialyzers (2005), 20 descendants of its own
- K082414: Optiflux F250NR, Model 0500325E (2008), 16 descendants of its own
- K123262: Optiflux Ultra Dialyzer (2014), 13 descendants of its own
- K152367: Optiflux dialyzer (2015), 12 descendants of its own

## Recalls of this device
- Mar 31, 2005 · Not classified · Z-0790-05: Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.
- Oct 1, 2001 · Not classified · Z-0739-04: Customer reprocessing methods for the reuseable hollow fiber dialyzers may damage the hollow fibers and result in blood leaks during dialysis.

Source page: https://510kreport.com/device/K001250
Methodology: https://510kreport.com/methodology