# K042936: Solution Administration with Luer Access Injection Site

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Nov 26, 2004 after 32 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K915571 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984060: Luer Access Injection Site, Baxter Healthcare Corp (1999) Summary page 2.
- (no number) Nac PRN: named in the summary without a submission number

## Recalls of this device
- Dec 14, 2012 · Class II · Z-2687-2016: Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.

## Indications for use
IV/Catheter Extension Set with NAG Plus Needleless Access Connector is intended to administer drugs and solutions into a patient's vascular system. The NAC Plus (integral or stand-alone) allows the user to administer or withdraw solutions. The NAC Plus Needleless Access Connector, available as a stand-alone accessory or as part of the IV/Catheter Extension set, may aid in the prevention of needlestick injury.

Source page: https://510kreport.com/device/K042936
Methodology: https://510kreport.com/methodology