# K122952: Nipro Pureflux-L Hemodialyzer

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corporation
- Decided: Dec 4, 2013 after 435 days
- Product code: FJI (Dialyzer, Capillary, Hollow Fiber)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 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)
- K062079: Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210, Baxter Healthcare Corporation (2006) Summary page 1.
- K926005: Fresenius Hemoflow, Various Models, Fresenius USA, Inc. (1994) Summary page 1.
- K043244: Fresenius Optiflux F20NR, FF18NR, F16NR, Fresenius Medical Care North America (2004) Summary page 1.

## Indications for use
Hemodialysis with a PUREFLUX-L 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. The device is for prescription use only. This product is intended for single use only. The performance properties of reused dialyzers have not been established.

Source page: https://510kreport.com/device/K122952
Methodology: https://510kreport.com/methodology