# K133547: Nxstage System One with Nxview

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Mar 3, 2014 after 104 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K921456 (1994). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122051: Nxstage System One, Nxstage Medical, Inc. (2013) Summary page 2.
- K040074: Oneview Interface, Nxstage Medical, Inc. (2004) Summary page 2.

## Most influential descendants
- K252377: NxStage System One with NxView (2026), 0 descendants of its own

## Recalls of this device
- Oct 29, 2015 · Class II · Z-0326-2016: Ultrafiltration (UF) Volume software error inaccurate fluid removal
- Oct 29, 2015 · Class II · Z-0327-2016: Ultrafiltration (UF) Volume software error inaccurate fluid removal

## Indications for use
NxStage System One: The NxStage System One is indicated for the treatment of acute and chronic renal failure, or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. 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. NxView: NxView is a computer-based touch screen user interface that provides on-line instructions for use, summarized system information and remote access. NxView is contraindicated as the sole method of monitoring a patient during treatment.

Source page: https://510kreport.com/device/K133547
Methodology: https://510kreport.com/methodology