# K935471: Filtryzer (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Toray Industries (America), Inc.
- Decided: May 19, 1995 after 550 days
- Product code: FJI (Dialyzer, Capillary, Hollow Fiber)
- Device class: 2
- Regulation: 21 CFR 876.5820
- 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.
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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K994198: Hemofeel-CH, Models CH-0.35L, CH-0.6L, CH-1.0L (2000), 0 descendants of its own

## Recalls of this device
- Dec 30, 2003 · Not classified · Z-0349-04: Potential loose header (end cap) on hollow fiber dialyzers.
- Dec 30, 2003 · Not classified · Z-0351-04: Potential loose header (end cap) on hollow fiber dialyzers.

Source page: https://510kreport.com/device/K935471
Methodology: https://510kreport.com/methodology