# K140831: Maxzero Extension Set with Needless Connector

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Apr 15, 2014 after 13 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.
13 later devices descend from it; 6 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132413: MZ1000, Care Fusion (2013) Summary page 1.
- K083472: Medegen Pressure Rated Extension Sets, Medegen, Inc. (2008) Summary page 1.
- K051499: Intravascular Administration Set and Extension Set, Medegen Medical Manufacturing Services (2005) Summary page 1.

## Most influential descendants
- K162804: Q2 Low Pressure Power Injection Extension Set (2017), 4 descendants of its own
- K182897: Velano Vascular Q2 Extension Set (2019), 3 descendants of its own
- K153293: Extension Set (2016), 3 descendants of its own
- K200439: Velano ExT Extension Set (2021), 2 descendants of its own
- K251257: nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] (2025), 0 descendants of its own

## Indications for use
Pressure Rated: The MaxZero multi fuse extension set with needleless connector(s) is for single use only. The extension set may 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 325 psi at a flow rate of 10mL per second. Non Pressure Rated: The MaxZero multi fuse extension set with needleless connector(s) is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration.

Source page: https://510kreport.com/device/K140831
Methodology: https://510kreport.com/methodology