# K030050: Toraysulfone Dialyzer, BS-L Series

- Pathway: 510(k) (Traditional)
- Applicant: Toray Industries (America), Inc.
- Decided: Sep 29, 2003 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: 1 generation back to K002277 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002512: Toraysulfone Dialyzer, Toray Industries (America), Inc. (2001)
- K002277: Fresenius Optiflux 200NR, Fresenius Medical Care North America (2000) Summary page 1.

## Indications for use
The Toraysulfone Dialyzer, BS-L Series, is indicated for use in hemodialysis treatment of patients with acute or chronic renal failure.

Source page: https://510kreport.com/device/K030050
Methodology: https://510kreport.com/methodology