# K170469: NxStage System One Plus

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: May 9, 2017 after 82 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 K093069 (2010). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141752: Nxstage System One, Nxstage Medical, Inc. (2014) Summary page 4.

## Most influential descendants
- K230632: VersiHD with GuideMe software (2023), 0 descendants of its own

## Indications for use
The NxStage System One Plus 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 System is also indicated for home hemodialysis, including home nocturnal hemodialysis. All treatments must be administered under physician’s prescription, and must be performed 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/K170469
Methodology: https://510kreport.com/methodology