# K041424: Nxstage System One

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Jul 2, 2004 after 35 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: 4 generations back to K001283 (2001). 8 ancestors in all.
28 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030470: Nxstage System One, Nxstage Medical, Inc. (2003) Summary page 2.
- (no number) Fresenius 2008K: named in the summary without a submission number

## Most influential descendants
- K050525: Nxstage System One (2005), 27 descendants of its own
- K062079: Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 (2006), 26 descendants of its own
- K083778: Xenium XPH, Models 110, 130, 150, 170, 190 and 210 (2009), 20 descendants of its own
- K082414: Optiflux F250NR, Model 0500325E (2008), 16 descendants of its own
- K123262: Optiflux Ultra Dialyzer (2014), 13 descendants of its own

## Indications for use
The NxStage System One is indicated for the treatment of renal failure or fluid overload using hemofiltration, hemodialysis and/or ultrafiltration. All treatments must be administered by a health care provider, under physician prescription.

Source page: https://510kreport.com/device/K041424
Methodology: https://510kreport.com/methodology