# K926005: Fresenius Hemoflow, Various Models

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius USA, Inc.
- Decided: Aug 23, 1994 after 634 days
- Product code: FJI (Dialyzer, Capillary, Hollow Fiber)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K131381: Elisio-H Hemodialyzer (2013), 2 descendants of its own
- K140191: Elisio-H Hemodialyzer (2014), 1 descendant of its own
- K260533: Elisio™-H (2026), 0 descendants of its own
- K122952: Nipro Pureflux-L Hemodialyzer (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K926005
Methodology: https://510kreport.com/methodology