# K061837: Nxstage Cartridge Express

- Pathway: 510(k) (Special)
- Applicant: Nxstage Medical, Inc.
- Decided: Jul 31, 2006 after 32 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K955592 (1997). 8 ancestors in all.
4 later devices descend from it; 4 cite 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)
- K050727: Modification to Nxstage Cartridge Express, Nxstage Medical, Inc. (2005) Summary page 2.

## Most influential descendants
- 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
- K123395: Nxstage System One Low Volume Cartridge Express (2013), 0 descendants of its own

## Recalls of this device
- Jul 27, 2007 · Not classified · Z-1228-2007: Potential for dialysate leaks from the cartridge during treatment.

## 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 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/K061837
Methodology: https://510kreport.com/methodology