# K162248: Asahi ViE-U Series Dialyzer

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Kasei Medical Co., Ltd.
- Decided: May 3, 2017 after 266 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K926373 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001250: Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models), Asahi Medical Co., Ltd. (2000) Summary page 4.
- K041726: High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models Aps-R, -M, -S, -E, and -EX, Asahi Medical Co., Ltd. (2004) Summary page 4.
- K003425: Clirans E-Series Hollow Fiber Dialyzers, Terumo Medical Corp. (2001) Summary page 4.
- K013550: Clirans E-Series Dialyzer, Terumo Medical Corp. (2001) Summary page 4.

## Indications for use
ViE-U is intended for use in hemodialysis for the treatment of patients who have acute or chronic renal failure. ViE-U is intended for single use only.

Source page: https://510kreport.com/device/K162248
Methodology: https://510kreport.com/methodology