# MOT: Irradiator, Blood To Prevent Graft Versus Host Disease

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 16
- Recalls: 1 (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)
- 1995: 3
- 1996: 1
- 1998: 1
- 2003: 1
- 2005: 2
- 2009: 1
- 2016: 1
- 2017: 1
- 2019: 1
- 2020: 1

## Most-cited predicates
- K051065: Raycell X-Ray Blood Irradiator (2005), cited by 2
- K974210: Shielded Cabinet X-Ray Radiation Source Device Model RS 3000 (1998), cited by 2
- K161324: Raycell Mk2 (2016), cited by 1
- K082921: Rad Source X-Ray Blood Irradiator, Model RS-3400 (2009), cited by 1
- K865027: Irradiator for Biological Materials, Ibl-137C (1987), cited by 1
- K963497: Gammacell 3000 Elan, Version 1.0 and Gammacell 1000 Elite, Version 1.0 (1996), cited by 1
- K172087: Sangray (2017), cited by 1
- K952291: Gammacell 3000 Elan (1995), cited by 1

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