# K193088: MaxZero Extension Sets with Needle-Free Connector (s)

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion, Inc.
- Decided: Oct 23, 2020 after 352 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 4.

## Indications for use
The MaxZero™ extension set with needle-free connector(s) is for single use only. The MaxZero™ extension set with needle-free connector(s) may be used for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids.

Source page: https://510kreport.com/device/K193088
Methodology: https://510kreport.com/methodology