# K261267: Careflux H60;Careflux H70;Careflux V500

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: Jul 24, 2026 after 99 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). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K162488: Optiflux dialyzer, Fresenius Medical Care North America (2017) Summary page 5.

## Indications for use
Careflux H60 and H70 The careflux dialyzers are intended for single use only for extracorporeal blood purification during the intermittent kidney replacement therapies hemodialysis (HD) and isolated ultrafiltration for patients suffering from kidney disease. Careflux V500 The careflux dialyzers are intended for single use only for extracorporeal blood purification during the intermittent kidney replacement therapies hemodialysis (HD) and hemodiafiltration (HDF) using pre-, post-, or mixed dilution modes, and isolated ultrafiltration for patients suffering from kidney disease.

Source page: https://510kreport.com/device/K261267
Methodology: https://510kreport.com/methodology