# K143313: NxStage Therapeutic Plasma Exchange (TPE) Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Mar 20, 2015 after 121 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: 1 generation back to K093069 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093069: Nxstage System One with Therapeutic Plasma Exchange Cartridge, Nxstage Medical, Inc. (2010) Summary page 5.

## Indications for use
The NxStage TPE Cartridge is indicated for use only with the NxStage System One 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/K143313
Methodology: https://510kreport.com/methodology