# K984060: Luer Access Injection Site

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jul 26, 1999 after 255 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: 1 generation back to K915571 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970855: Clave Connector, Icu Medical, Inc. (1997) Summary page 2.
- K915571: Clave Connector, Icu Medical, Inc. (1992) Summary page 2.

## Most influential descendants
- K042936: Solution Administration with Luer Access Injection Site (2004), 0 descendants of its own

## Indications for use
The proposed luer access injection site and sets incorporating it will be used with a vascular access device for fluid administration and blood sampling. The luer access injection site can be connected to male luer adapters, (e.g., syringes or sets) to allow needleless access to the vascular path. This device is for use as part of a program to reduce needle-stick injuries and the associated transmission of blood borne pathogens.

Source page: https://510kreport.com/device/K984060
Methodology: https://510kreport.com/methodology