# K072576: Clearlink Antimicrobial Luer Activated Device (Lad) and Extension Sets with the Clearlink Antimicrobial Luer Activated

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Nov 6, 2007 after 54 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: 2 generations back to K915571 (1992). 4 ancestors in all.
4 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)
- K003225: Solution Administration Sets with Capless Luer Activated Valve, Baxter Healthcare Corp (2000) Summary page 2.
- K973916: NP Medical Capless Luer Activated Valve, Np Medical, Inc. (1998) Summary page 2.

## Most influential descendants
- K081289: V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device (2008), 3 descendants of its own
- 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 CLEARLINK 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 CLEARLINK Antimicrobial Luer Activated Device contains an antimicrobial agent (metallic silver) that may inhibit the growth of microorganisms on the coated surfaces of the CLEARLINK device. The antimicrobial agent is intended to reduce the possibility that the device may become microbially contaminated. The antimicrobial agent is not intended to be used as a treatment for existing infections.

Source page: https://510kreport.com/device/K072576
Methodology: https://510kreport.com/methodology