# K242053: FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: Mar 21, 2025 after 252 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: 12 generations back to K001283 (2001). 37 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220721: FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000, Fresenius Medical Care Renal Therapies Group, LLC (2023) Summary page 5.
- K190459: Hemoflow F3 and F4 Dialyzers, Fresenius Medical Care Renal Therapies Group, LLC (2019) Summary page 5.

## Most influential descendants
- K253518: FX CorAL 40; FX CorAL 50 (2025), 0 descendants of its own

## Indications for use
FX CorAL HD dialyzers are intended for hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration in patients, including pediatric patients, with acute kidney injury or chronic kidney disease 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/K242053
Methodology: https://510kreport.com/methodology