# K020858: Nxstage Therapy System

- Pathway: 510(k) (Special)
- Applicant: Nxstage Medical, Inc.
- Decided: Apr 17, 2002 after 30 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: 2 generations back to K001283 (2001). 2 ancestors in all.
32 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012510: Modification to: Lifemate Hemofiltration System, Nxstage Medical, Inc. (2001) Summary page 2.

## Most influential descendants
- K030470: Nxstage System One (2003), 29 descendants of its own
- K041424: Nxstage System One (2004), 28 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K020858
Methodology: https://510kreport.com/methodology