# IYT: System, Rebreathing, Radionuclide

- Device class: 2; regulation: 21 CFR 892.1390; FDA's rule: 510(k) required
- FDA decisions: 49
- 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)
- 1985: 14
- 1986: 7
- 1987: 2
- 1988: 3
- 1990: 6
- 1991: 4
- 1992: 1
- 1995: 2
- 2020: 1
- 2026: 1

## Most-cited predicates
- K810819: Medi/Nuclear #XE-102 Xenon/Master (1981), cited by 1
- K865084: Amici Xenon Rebreathing System* (1987), cited by 1
- K913416: Tetley Patient Administration Set (1991), cited by 1

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