# K171118: Carefusion NeutraClear multi-fuse Extension Set with needle-free connector (s)

- Pathway: 510(k) (Traditional)
- Applicant: Cair Lgl
- Decided: Aug 15, 2017 after 123 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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 K942988 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140831: Maxzero Extension Set with Needless Connector, Care Fusion (2014) Summary page 5.

## Indications for use
Non- pressure rated: The Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) is for single use only. The extension set can be used for direct injection, intermittent infusion, continuous infusion, or aspiration. Pressure rated: The Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) is for single use only. The extension set can be used for direct injection, intermittent infusion, continuous infusion, or aspiration. This set may be used with power injector procedures to a maximum pressure of 325psi at a flow rate of 10mL/s.

Source page: https://510kreport.com/device/K171118
Methodology: https://510kreport.com/methodology