# K123395: Nxstage System One Low Volume Cartridge Express

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Mar 7, 2013 after 122 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: 6 generations back to K955592 (1997). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 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 3.
- K100364: Gambro Cartridge Blood Set Low Weight- Low Volume, Model 003422-520, Gambro Renal Products, Inc. (2010) Summary page 2.
- K032431: Prisma M60/M100 Sets, Gambro, Inc. (2003) Summary page 2.
- K071298: HF Junior Hemofilter, Minntech Corp. (2007) Summary page 2.
- K923312: High Permeability Dialyer, Minntech Corp. (1994) Summary page 2.

## Indications for use
The NxStage System One Low Volume Cartridge Express is indicated for use only with the NxStage System One in a chronic care dialysis facility or acute care unit, It is indicated for use in adult patients for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. All treatments must be administered under a 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/K123395
Methodology: https://510kreport.com/methodology