# K032766: Vitek 2 Gram Positive Linezolid

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Oct 31, 2003 after 56 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.
14 later devices descend from it; 3 cite it directly.
0 of 15 devices 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
- K050510: Echoview/Shimasonic Diagnostic Ultrasound System, Model Sdu-1100, Shimadzu Medical Systems (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K050075: Vitek 2 Gram Positive Daptomycin (2005), 6 descendants of its own
- K122547: Gram Postitve Clindamycin (2012), 5 descendants of its own
- K141149: Vitek 2 Ast GP Ceftaroline (2014), 4 descendants of its own
- K072668: Vitek 2 Gram Positive Vancomycin (2007), 4 descendants of its own
- K190616: VITEK 2 AST-Gram Positive Dalbavancin (<=  0.015 - >= 1 µg/mL) (2019), 3 descendants of its own

## Indications for use
VITEK@2 Gram Positive Linezolid is designed for antimicrobial susceptibility testing of Enterococcus faecalis, E. faecium, Staphylococcus aureus, S. epidermidis, S. haemolyficus and Streptococcus agalactiae. 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/K032766
Methodology: https://510kreport.com/methodology