# JTY: Culture Media, For Isolation Of Pathogenic Neisseria

- Device class: 2; regulation: 21 CFR 866.2410; FDA's rule: 510(k) required
- FDA decisions: 83
- 510(k) review time 2021–2025: median 239 days (middle half 239–239)
- Recalls: 5 (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)
- 1985: 7
- 1986: 2
- 1987: 4
- 1988: 2
- 1993: 3
- 1994: 2
- 1995: 1
- 1996: 1
- 1999: 1
- 2021: 1

## Most-cited predicates
- K993033: Intray GC (1999), cited by 1

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