# K113023: Streamline Airless System Set with Pre-Attached Dialyzer

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Dec 21, 2012 after 437 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K132602: Streamline Express (2014), 0 descendants of its own
- K131050: Nxstage 1.6M2 Dialyzer (2013), 0 descendants of its own

## Indications for use
The single use blood tubing set with pre-attached dialyzer is indicated for use with the B. Braun Dialog Series hemodialysis systems for the treatment of acute and chronic renal failure. There are no known contraindications.

Source page: https://510kreport.com/device/K113023
Methodology: https://510kreport.com/methodology