# K143234: MaxZero Administration Sets

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Nov 20, 2014 after 10 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: 6 generations back to K942988 (1995). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051499: Intravascular Administration Set and Extension Set, Medegen Medical Manufacturing Services (2005) Summary page 5.
- K132413: MZ1000, Care Fusion (2013) Summary page 5.

## Indications for use
The MaxZero Intravascular Administration set with needleless connector(s) is a device used to administer fluids from a container to a patient’s vascular system. The administration set is for single patient use only. The administration set can be used for direct injection, intermittent infusion or continuous infusion.

Source page: https://510kreport.com/device/K143234
Methodology: https://510kreport.com/methodology