# K081289: V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Aug 4, 2008 after 89 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: 3 generations back to K915571 (1992). 5 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072576: Clearlink Antimicrobial Luer Activated Device (Lad) and Extension Sets with the Clearlink Antimicrobial Luer Activated, Baxter Healthcare Corp (2007) Summary page 2.

## Most influential descendants
- K103551: Interlink S / Clearlink System / V-Link Lad with Vitalshield Protective Coating Non-Dehp Catheter Extension Set Kits, (2011), 0 descendants of its own
- K093489: IN Vision-Plus Nano with Neutral Advantage Technology (2010), 0 descendants of its own
- K090189: Antimicrobial Clave, Models AG Clave, AG Microclave (2009), 0 descendants of its own

## Indications for use
Intended for use with a vascular access device for the administration of drugs and solutions. The V-Link Antimicrobial Luer Activated 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. The V-Link Antimicrobial Luer Activated Device contains an antimicrobial agent (metallic silver) that may reduce the growth of microorganisms on the coated surfaces of the V-Link device. The antimicrobial agent is not intended to be used as a treatment for existing infections.

Source page: https://510kreport.com/device/K081289
Methodology: https://510kreport.com/methodology