# K032788: Vitek 2 Gram Negative Gatifloxacin

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Nov 4, 2003 after 57 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.
31 later devices descend from it; 2 cite it directly.
1 of 32 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) VITEK 2 Gram Negative Susceptibility Test for Cefpodoxime: named in the summary without a submission number

## Most influential descendants
- K041982: Vitek 2 Gram Negative Ertapenem (2004), 29 descendants of its own
- K072038: Vitek 2 Gram Negative Levofloxacin (2007), 26 descendants of its own
- K082346: Vitek 2 Gram Negative Doripenem (2009), 22 descendants of its own
- K091899: Vitek 2 Gram Negative Meropenem (2009), 21 descendants of its own
- K103752: Vitek 2 Systems (PC) 5.02 Software (2011), 19 descendants of its own

## Indications for use
VITEK®2 Gram Negative Gatifloxacin is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Acinetobacter lwoffii, Citrobacter koseri, C. freundii, Enterobacter aerogenes, E. cloacae, Klebsiella oxytoca, Morganella morganii, and Proteus vulgaris. 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/K032788
Methodology: https://510kreport.com/methodology