# K183524: VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Mar 12, 2019 after 83 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.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K191766: VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL) (2019), 7 descendants of its own
- K213931: VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) (2022), 2 descendants of its own
- K222073: VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) (2023), 1 descendant of its own
- K251579: VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (2025), 0 descendants of its own
- K222430: VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K183524
Methodology: https://510kreport.com/methodology