# K122051: Nxstage System One

- Pathway: 510(k) (Special)
- Applicant: Nxstage Medical, Inc.
- Decided: Apr 23, 2013 after 285 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K093069 (2010). 1 ancestor in all.
9 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093069: Nxstage System One with Therapeutic Plasma Exchange Cartridge, Nxstage Medical, Inc. (2010)

## Most influential descendants
- K140526: Nxstage System One (2014), 6 descendants of its own
- K141752: Nxstage System One (2014), 5 descendants of its own
- K170469: NxStage System One Plus (2017), 1 descendant of its own
- K150472: NxStage System One (2015), 1 descendant of its own
- K133547: Nxstage System One with Nxview (2014), 1 descendant of its own

## Recalls of this device
- Oct 29, 2015 · Class II · Z-0335-2016: Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed

## Indications for use
The NxStage System One is indicated for the treatment of acute and chronic renal failure, or fluid overload using hemorfiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The System is also indicated for hemodialysis with or without ultrfltration in the home. The NxStage System One is also indicated for Therapeutic Plasma Exchange in a clinical environment All treatments must be administered under physician's prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

Source page: https://510kreport.com/device/K122051
Methodology: https://510kreport.com/methodology