# K014152: Nxstage Cartridge Express

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Dec 11, 2002 after 358 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: 2 generations back to K955592 (1997). 5 ancestors in all.
7 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)
- K002210: Syntra Dialyzer, Model Syntra 120, 160, Baxter Healthcare Corp (2001)
- K982414: Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters, Gambro Healthcare (1999) Summary page 1.
- K923312: High Permeability Dialyer, Minntech Corp. (1994) Summary page 1.
- K946279: Prisma CFM (Continuous Fluid Management System), Cobe Renal Care, Inc. (1997). Our reading of the summary gave K942679, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Prisma CFM System hemofilter”.

## Most influential descendants
- K032356: Nxstage System One with Cartridge Express (2003), 6 descendants of its own
- 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

## Indications for use
The NxStage Therapy System is indicated for treatment of renal failure or fluid overload using hemofiltration and/or ultrafiltration. The NxStage Cartridge Express is part of the NxStage Therapy System and is intended for use with the NxStage Cycler.

Source page: https://510kreport.com/device/K014152
Methodology: https://510kreport.com/methodology