# K083765: Maxguard Advanced Luer Activated Device with Antimicrobial

- Pathway: 510(k) (Traditional)
- Applicant: Medegen Medical Manufacturing Services
- Decided: Dec 30, 2008 after 12 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The MaxGuard Advanced Luer Activated Device with Antimicrobial Technology is a sterile single use positive displacement connector for needleless access to the IV line and/or IV catheter during IV therapy. The MaxGuard Connector can be used for direct injection, intermittent infusion, continuous infusion or aspiration. The MaxGuard with Antimicrobial Technology may inhibit the growth of microorganisms on the surfaces of the MaxGuard 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. The MaxGuard with Antimicrobial Technology has been shown to provide a 4+ log reduction of the following organisms: Staphylococcus aureus, ATCC 6558 Staphylococcus epidermidis, ATCC 12228 Escherichia coli, ATCC 8739 Enterococcus faecalis, ATCC 51299 Pseudomonas aeruginosa, ATCC 9027 Klebsiella pneumonia, ATCC 4352 Candida albicans, ATCC 10231

Source page: https://510kreport.com/device/K083765
Methodology: https://510kreport.com/methodology