# K140526: Nxstage System One

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: May 19, 2014 after 76 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 K093069 (2010). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 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.

## Most influential descendants
- 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
- K233557: HemoCare Hemodialysis System (2024), 0 descendants of its own
- K230632: VersiHD with GuideMe software (2023), 0 descendants of its own

## Recalls of this device
- Oct 29, 2015 · Class II · Z-0336-2016: 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
- Oct 29, 2015 · Class II · Z-0337-2016: 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 hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The NxStage System One is also indicated for hemodialysis with or without ultrafiltration in the home. 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/K140526
Methodology: https://510kreport.com/methodology