# K003425: Clirans E-Series Hollow Fiber Dialyzers

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Feb 1, 2001 after 90 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.
2 later devices descend from it; 2 cite 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
- K013550: Clirans E-Series Dialyzer (2001), 1 descendant of its own
- K162248: Asahi ViE-U Series Dialyzer (2017), 0 descendants of its own

## Recalls of this device
- Mar 31, 2005 · Not classified · Z-0791-05: Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.
- Mar 31, 2005 · Not classified · Z-0792-05: Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.

Source page: https://510kreport.com/device/K003425
Methodology: https://510kreport.com/methodology