# K203062: Optiflux Series of Dialyzers F160NR,  F180NR, F200NR

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: Dec 28, 2020 after 80 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.
1 later device descends from it; 1 cites it directly.
0 of 36 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
- K260533: Elisio™-H (2026), 0 descendants of its own

## Indications for use
Optiflux dialyzers are intended for hemodialysis, hemodiafiltration, hemofiltration, 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/K203062
Methodology: https://510kreport.com/methodology