# K181737: Raycell MK1

- Pathway: 510(k) (Traditional)
- Applicant: Best Theratronics Limited
- Decided: Jan 2, 2019 after 184 days
- Product code: MOT (Irradiator, Blood To Prevent Graft Versus Host Disease)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K051065 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161324: Raycell Mk2, Best Theratronics Limited (2016) Summary page 4.

## Indications for use
To irradiate cellular blood products to inactivate T-lymphocytes in order to prevent Graft Versus Host Disease.

Source page: https://510kreport.com/device/K181737
Methodology: https://510kreport.com/methodology