# K220721: FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: May 11, 2023 after 423 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: 11 generations back to K001283 (2001). 34 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162488: Optiflux dialyzer, Fresenius Medical Care North America (2017) Summary page 4.
- K043342: Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR, Gambro Renal Products (2005) Summary page 4.

## Most influential descendants
- 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) (2025), 2 descendants of its own
- K242053: FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) (2025), 1 descendant of its own
- K240394: multiFlux 1000 (F00012408) (2024), 1 descendant of its own
- K261267: Careflux H60;Careflux H70;Careflux V500 (2026), 0 descendants of its own
- K252459: multiFlux 130 (F00013123); multiFlux 160 (F00013124) (2026), 0 descendants of its own

## Indications for use
FX CorAL dialyzers are intended for hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration in patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.

Source page: https://510kreport.com/device/K220721
Methodology: https://510kreport.com/methodology