# K032356: Nxstage System One with Cartridge Express

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Oct 28, 2003 after 90 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: 3 generations back to K955592 (1997). 6 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014152: Nxstage Cartridge Express, Nxstage Medical, Inc. (2002) Summary page 2.
- K946279: Prisma CFM (Continuous Fluid Management System), Cobe Renal Care, Inc. (1997) Summary page 1.

## Most influential descendants
- K050727: Modification to Nxstage Cartridge Express (2005), 5 descendants of its own
- K061837: Nxstage Cartridge Express (2006), 4 descendants of its own
- K232803: NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) (2024), 0 descendants of its own
- K183158: NxStage Cartridge Express with Speedswap (2019), 0 descendants of its own
- K131050: Nxstage 1.6M2 Dialyzer (2013), 0 descendants of its own

## Indications for use
The NxStage System One is indicated for treatment of renal failure or fluid overload using hernofiltration, hemodialysis, and/or ultrafiltration. All treatments must be administered by a health care provider, under physician’s prescription.

Source page: https://510kreport.com/device/K032356
Methodology: https://510kreport.com/methodology