# LTW: Susceptibility Test Cards, Antimicrobial

- Device class: 2; regulation: 21 CFR 866.1640; FDA's rule: 510(k) required
- FDA decisions: 17
- Recalls: 8 (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)
- 1992: 2
- 1993: 1
- 1994: 4
- 1995: 5
- 1996: 4
- 1997: 8
- 1998: 3
- 1999: 20
- 2000: 34
- 2001: 7

## Most-cited predicates

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