# K132734: Neutral Luer Activated Device (One-Link Needle-Free IV Connector) and Extension Sets

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corp
- Decided: Oct 8, 2013 after 35 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K942988 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120443: Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated Device, Baxter Healthcare Corporation - Renal Division (2012) Summary page 2.

## Recalls of this device
- Dec 21, 2020 · Class II · Z-1102-2021: There were customer reports of separation between the tubing and Male Luer Lock Adaptor.
- May 21, 2015 · Class II · Z-0132-2016: Potential for a leak at the tubing to luer bond.

## 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.

Source page: https://510kreport.com/device/K132734
Methodology: https://510kreport.com/methodology