# K183158: NxStage Cartridge Express with Speedswap

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Aug 9, 2019 after 267 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: 6 generations back to K955592 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061837: Nxstage Cartridge Express, Nxstage Medical, Inc. (2006) Summary page 5.

## Recalls of this device
- Jan 29, 2024 · Class II · Z-1191-2024: Product is recalled due to reports of blood leaking or spraying from the arterial line on the cartridge.If this failure occurs, a patient may experience uncontrolled blood loss or a healthcare profess

## 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 care facility. The NxStage Cartridge Express with Speedswap is an optional accessory device to be used exclusively with the NxStage System One for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal failure or fluid overload. The device would be used when hemofiltration, hemodialysis, and /or ultrafiltration may become disrupted. All treatments must be administered under a 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/K183158
Methodology: https://510kreport.com/methodology