# K253518: FX CorAL 40; FX CorAL 50

- Pathway: 510(k) (Special)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: Dec 18, 2025 after 36 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: 13 generations back to K001283 (2001). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242053: FX CorAL 40 (F00009214); FX CorAL 50 (F00009215), Fresenius Medical Care Renal Therapies Group, LLC (2025) Summary page 5.
- K243874: FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975), Fresenius Medical Care Renal Therapies Group, LLC (2025) Summary page 5.

## Indications for use
The FX CorAL hemodialyzers are intended for single use only for extracorporeal blood purification during intermittent renal replacement therapies hemodialysis (HD), hemodiafiltration (HDF) using pre-, post or mixed-dilution modes, and isolated ultrafiltration for patients suffering from renal insufficiency, including pediatric patients. 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/K253518
Methodology: https://510kreport.com/methodology