# K874872: Fresenius Hemoflow F3, F4, F5, F7

- Pathway: 510(k) (Traditional)
- Applicant: Seratronics, Inc.
- Decided: Feb 19, 1988 after 84 days
- Product code: FJI (Dialyzer, Capillary, Hollow Fiber)
- Device class: 2
- Regulation: 21 CFR 876.5820
- 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K190459: Hemoflow F3 and F4 Dialyzers (2019), 2 descendants of its own
- K242053: FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) (2025), 1 descendant of its own
- K253518: FX CorAL 40; FX CorAL 50 (2025), 0 descendants of its own

## Recalls of this device
- Feb 26, 2016 · Class II · Z-1324-2016: Dialyzer header leak due to possible improper torque

Source page: https://510kreport.com/device/K874872
Methodology: https://510kreport.com/methodology