# K171331: NxStage System One

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Aug 24, 2017 after 108 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: 5 generations back to K093069 (2010). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150472: NxStage System One, Nxstage Medical, Inc. (2015) Summary page 5.

## 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 System is also indicated for home hemodialysis, including home nocturnal hemodialysis and solo home hemodialysis during waking hours. 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/K171331
Methodology: https://510kreport.com/methodology