# K090189: Antimicrobial Clave, Models AG Clave, AG Microclave

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Apr 10, 2009 after 74 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: 4 generations back to K915571 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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 1.
- K072576: Clearlink Antimicrobial Luer Activated Device (Lad) and Extension Sets with the Clearlink Antimicrobial Luer Activated, Baxter Healthcare Corp (2007) Summary page 1.
- K081289: V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device, Baxter Healthcare Corp (2008) Summary page 1.

## Indications for use
The Antimicrobial CLAVE® Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to an intravascular administration set for the administration of fluids to a patient through a cannulae placed in the vein or artery. The connector includes two antimicrobial agents. The first agent is compounded with liquid silicone rubber to provide a protective seal around the cannula. The second, agent is compounded with the polycarbonate alloy and is intended to reduce microbial contamination in the device fluid path. The antimicrobial agents are not intended for treating existing patient infections.

Source page: https://510kreport.com/device/K090189
Methodology: https://510kreport.com/methodology