# LIE: Reagent/Device, Inoculum Calibration

- Device class: 2; regulation: 21 CFR 866.1640; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 317 days (middle half 317–317)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1982: 1
- 1989: 1
- 1991: 1
- 1994: 1
- 2011: 2
- 2023: 1

## Most-cited predicates
- K820299: Prompt Inoculation System (1982), cited by 1

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