# GMT: Antigens, Ha, Treponema Pallidum

- Device class: 2; regulation: 21 CFR 866.3830; FDA's rule: 510(k) required
- FDA decisions: 9
- Recalls: 0 (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)
- 1976: 1
- 1979: 2
- 1989: 1
- 1990: 1
- 1991: 3
- 1997: 1

## Most-cited predicates
- K971502: Serodia TP-PA (1997), cited by 1

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