# IWI: Source, Isotope, Sealed, Gold, Titanium, Platinum

- Device class: 2; regulation: 21 CFR 892.5730; FDA's rule: 510(k) required
- FDA decisions: 6
- 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)
- 1986: 1
- 1987: 1
- 1989: 1
- 1991: 1
- 1994: 1
- 1998: 1

## Most-cited predicates
- K940632: I-125 Rapid Strand (1994), cited by 7
- K874787: Modified Palladium Seed Model 100 (1987), cited by 4
- K852542: Palladium Seed Model 100 (1986), cited by 1

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