# K132413: MZ1000

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Aug 29, 2013 after 27 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: 5 generations back to K942988 (1995). 13 ancestors in all.
26 later devices descend from it; 6 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072542: Maxplus Tru-Swab Positive Displacement Connector, Medegen Medical Manufacturing System (2007) Summary page 1.
- K100434: Clave Neutron, Icu Medical, Inc. (2010) Summary page 1.
- K120443: Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated Device, Baxter Healthcare Corporation - Renal Division (2012) Summary page 1.

## Most influential descendants
- K140831: Maxzero Extension Set with Needless Connector (2014), 13 descendants of its own
- K170336: BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector (2017), 6 descendants of its own
- K183399: BD Nexiva Closed IV Catheter System (2019), 5 descendants of its own
- 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

## Indications for use
The MZ1000 is a sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy. The MZ1000 can be used for direct injection, intermittent infusion, continuous infusion or aspiration

Source page: https://510kreport.com/device/K132413
Methodology: https://510kreport.com/methodology