# K032861: Vitek 2 Gram Negative Moxifloxacin

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Nov 12, 2003 after 61 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- 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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K020510: Smoke Evacuation Hoses/Tubing, Dm Medical, Inc. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The VITEK 2@Gram Negative Moxifloxacin is designed for antimicrobial susceptibility testing of Klebsiella pneumoniae, Cifrobacfer freundii, Enferobacfer cloacae, Escherichia coli, Klebsiella oxyfoca and Proteus mirabilis. It is intended for use with the VITEK 2" System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

Source page: https://510kreport.com/device/K032861
Methodology: https://510kreport.com/methodology