# K171117: Carefusion NeutraClear Needle-free connector (EL-NC1000)

- Pathway: 510(k) (Traditional)
- Applicant: Cair Lgl
- Decided: Sep 1, 2017 after 140 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: 3 generations back to K970855 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133073: Cair Drive, Neutraclear, Cair Lgl (2014) Summary page 4.

## Indications for use
Carefusion NeutraClear™ Needle-free Connector is a bidirectional valve allowing injections and infusions to be given or sample taken via an intravenous line; or samples taken via arterial line. It seals and protects the line when it is not activated. The NeutraClear™ needle-free connector may be used with low-pressure power injectors procedures to a maximum pressure of 325psi with a flow at 10mL per second

Source page: https://510kreport.com/device/K171117
Methodology: https://510kreport.com/methodology