# K162488: Optiflux dialyzer

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care North America
- Decided: Apr 6, 2017 after 211 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K001283 (2001). 24 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152367: Optiflux dialyzer, Fresenius Medical Care North America (2015) Summary page 4.

## Most influential descendants
- K220721: FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 (2023), 6 descendants of its own
- 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
- K203062: Optiflux Series of Dialyzers F160NR,  F180NR, F200NR (2020), 1 descendant of its own

## Recalls of this device
- Aug 29, 2025 · Class II · Z-0041-2026: To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firm
- Dec 5, 2024 · Class II · Z-0801-2025: Potential for internal blood leaks due to cracked polyurethane
- May 4, 2022 · Class II · Z-1303-2022: Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
- Nov 5, 2018 · Class II · Z-0658-2019: Potential for external blood leaks from the dialyzer header

## Indications for use
Optiflux Dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

Source page: https://510kreport.com/device/K162488
Methodology: https://510kreport.com/methodology