# K132602: Streamline Express

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Feb 4, 2014 after 168 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: 2 generations back to K953823 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113023: Streamline Airless System Set with Pre-Attached Dialyzer, Nxstage Medical, Inc. (2012) Summary page 2.
- K080807: Blood Tubing Sets (Sterile Fluid Path), Nxstage Medical, Inc. (2008) Summary page 2.
- K994306: Reverso, Medisystems Corp. (2000) Summary page 2.

## Indications for use
The single use dialyzer with pre-attached blood tubing set is indicated for use with the Fresenius 2008 Series Hemodialysis systems for the treatment of acute and chronic renal failure.

Source page: https://510kreport.com/device/K132602
Methodology: https://510kreport.com/methodology