# K002512: Toraysulfone Dialyzer

- Pathway: 510(k) (Traditional)
- Applicant: Toray Industries (America), Inc.
- Decided: Oct 15, 2001 after 426 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K030050: Toraysulfone Dialyzer, BS-L Series (2003), 0 descendants of its own

## Recalls of this device
- Dec 30, 2003 · Not classified · Z-0352-04: Potential loose header (end cap) on hollow fiber dialyzers.

Source page: https://510kreport.com/device/K002512
Methodology: https://510kreport.com/methodology