# K093069: Nxstage System One with Therapeutic Plasma Exchange Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Oct 23, 2010 after 388 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
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K122051: Nxstage System One (2013), 9 descendants of its own
- K140526: Nxstage System One (2014), 6 descendants of its own
- K141752: Nxstage System One (2014), 5 descendants of its own
- K170469: NxStage System One Plus (2017), 1 descendant of its own
- K150472: NxStage System One (2015), 1 descendant of its own

## 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 indicated for hemodialysis with or without ultrafiltration in the home. The NxStage System One is also indicated for Therapeutic Plasma Exchange in a clinical environment. 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/K093069
Methodology: https://510kreport.com/methodology