# K133073: Cair Drive, Neutraclear

- Pathway: 510(k) (Traditional)
- Applicant: Cair Lgl
- Decided: Mar 20, 2014 after 171 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: 2 generations back to K970855 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120799: Arisure Neutral Valve, Yukon Medical, LLC (2012) Summary page 2.

## Most influential descendants
- K171117: Carefusion NeutraClear Needle-free connector (EL-NC1000) (2017), 0 descendants of its own

## Indications for use
Bidirectional needleless injection valve is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration sets for the administration or withdrawal of fluids from a patient through a cannula placed in the vein or for withdraw of fluids through the artery. Bidirectional needleless injection valve may be used with low-pressure power injectors with a flow at 10 ml/s, in state of connection.

Source page: https://510kreport.com/device/K133073
Methodology: https://510kreport.com/methodology