# K160444: FB-U Hemodialyzer

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corporation
- Decided: Feb 8, 2017 after 357 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). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131935: Elisio-H Hemodialyzer, Elisio-M Hemodialyzer, Nipro Medical Corporation (2013) Summary page 4.
- K030974: Exeltra High Flux Dialyzer, Models 150 & 170, Baxter Healthcare Corp (2003) Summary page 4.

## Indications for use
Hemodialysis with the FB-U Hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.

Source page: https://510kreport.com/device/K160444
Methodology: https://510kreport.com/methodology