# K190459: Hemoflow F3 and F4 Dialyzers

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: Aug 23, 2019 after 178 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
Longest line of descent: 1 generation back to K874872 (1988). 1 ancestor in all.
2 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)
- K874872: Fresenius Hemoflow F3, F4, F5, F7, Seratronics, Inc. (1988) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The Hemoflow F3 and F4 dialyzers are intended for hemodialysis of patients, including pediatric patients, with acute or chronic renal failure when conservative therapy is judged to be inadequate. Consider body and dialyzer surface area, blood flow, body weight, and extracorporeal blood volume when selecting dialyzers for use with pediatric patients.

Source page: https://510kreport.com/device/K190459
Methodology: https://510kreport.com/methodology