# K131050: Nxstage 1.6M2 Dialyzer

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Dec 27, 2013 after 256 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: 7 generations back to K001283 (2001). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 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 2.
- K113023: Streamline Airless System Set with Pre-Attached Dialyzer, Nxstage Medical, Inc. (2012) Summary page 2.
- K062079: Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210, Baxter Healthcare Corporation (2006) Summary page 4.

## Indications for use
The dialyzer is indicated for the treatment of acute and chronic renal failure or fluid overload using hemoflltration, hemodialysis. and/or ultrafiltration. There are no known contraindications.

Source page: https://510kreport.com/device/K131050
Methodology: https://510kreport.com/methodology