# LIO: Device, Specimen Collection

- Device class: 1; regulation: 21 CFR 866.2900; FDA's rule: 510(k) required
- FDA decisions: 63
- 510(k) review time 2021–2025: median 575 days (middle half 575–575)
- Recalls: 2 (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)
- 1996: 5
- 1998: 1
- 1999: 1
- 2001: 2
- 2007: 1
- 2008: 1
- 2011: 1
- 2012: 1
- 2013: 1
- 2024: 1

## Most-cited predicates
- K960997: Starswab Culture Collection and Transport System (1996), cited by 2
- K120846: Transport Culture Medium Device (2012), cited by 1

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