# JTO: Discs, Strips And Reagents, Microorganism Differentiation

- Device class: 1; regulation: 21 CFR 866.2660; FDA's rule: 510(k) exempt
- FDA decisions: 244
- Recalls: 17 (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)
- 1989: 5
- 1990: 5
- 1991: 15
- 1992: 7
- 1993: 15
- 1994: 12
- 1995: 8
- 1996: 5
- 1997: 4
- 2005: 1

## Most-cited predicates
- K813610: Rapid Strep (1982), cited by 1

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