# K190905: BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Jul 1, 2019 after 84 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
Longest line of descent: 1 generation back to K132909 (2014). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132909: BD Phoenix Automated Microbiology System Tigecycline (0.25-16 UG/ML), Becton, Dickinson and Company (2014) Summary page 3.

## Most influential descendants
- K211748: Selux AST System; Model AST Gen 1.0 (2023), 0 descendants of its own

## Indications for use
The BD Phoenix™ Automated Microbiology System is intended for the in vitro rapid identification (ID) and quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram negative aerobic and facultative anaerobic bacteria belonging to the family Enterobacteriaceae and non-Enterobacteriaceae.

Source page: https://510kreport.com/device/K190905
Methodology: https://510kreport.com/methodology