# K120443: Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated Device

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation - Renal Division
- Decided: May 22, 2012 after 98 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: 4 generations back to K942988 (1995). 7 ancestors in all.
28 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003225: Solution Administration Sets with Capless Luer Activated Valve, Baxter Healthcare Corp (2000) Summary page 2.
- K083472: Medegen Pressure Rated Extension Sets, Medegen, Inc. (2008) Summary page 2.
- K991653: Invision-Plus Injection Port Connector System, Rymed Technologies, Inc. (1999) Summary page 2.

## Most influential descendants
- K132413: MZ1000 (2013), 26 descendants of its own
- 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

## Indications for use
The Baxter Neutral Luer Activated Device is intended for single patient use with a vascular access device for the administration of drugs and solutions without needles, thus eliminating the potential for needle-stick injuries during use. This device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids. This device may be used with low pressure power injectors having a maximum pressure of 325 psi (2241 kPa) and a maximum flow rate of 10 mL/s.

Source page: https://510kreport.com/device/K120443
Methodology: https://510kreport.com/methodology