# LON: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

- Device class: 2; regulation: 21 CFR 866.1645; FDA's rule: 510(k) required
- FDA decisions: 303
- 510(k) review time 2021–2025: median 150 days (middle half 90–292)
- Recalls: 172 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 10
- 2018: 4
- 2019: 8
- 2020: 5
- 2021: 5
- 2022: 8
- 2023: 11
- 2024: 2
- 2025: 5
- 2026: 4

## Most-cited predicates
- K020321: BD Phoenix Automated Microbiology System (2002), cited by 103
- K020322: BD Phoenix Automated Microbiology System (2002), cited by 94
- K020323: BD Phoenix Automated Microbiology System (2002), cited by 91
- K063597: Vitek 2 Gram Positive Amoxicillin for Streptococcus Pneumoniae (2007), cited by 12
- K060324: BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent Gatifloxacin 0.25-8 UG/ML - Gram-Negative (2006), cited by 10
- K121546: Vitek 2 Gram Negative Doxycycline (2012), cited by 7
- K191766: VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL) (2019), cited by 5
- K053186: Vitek 2 Gram Positive Telithromycin for Streptococcus Pneumoniae (2005), cited by 4
- K072038: Vitek 2 Gram Negative Levofloxacin (2007), cited by 4
- K190616: VITEK 2 AST-Gram Positive Dalbavancin (<=  0.015 - >= 1 µg/mL) (2019), cited by 3

Source page: https://510kreport.com/product-code/LON
Data by year (CSV): https://510kreport.com/product-code/LON.csv