# K865027: Irradiator for Biological Materials, Ibl-137C

- Pathway: 510(k) (Traditional)
- Applicant: Cis-Us, Inc.
- Decided: Feb 26, 1987 after 65 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K974210: Shielded Cabinet X-Ray Radiation Source Device Model RS 3000 (1998), 4 descendants of its own
- K082921: Rad Source X-Ray Blood Irradiator, Model RS-3400 (2009), 2 descendants of its own
- K172087: Sangray (2017), 1 descendant of its own
- K201177: RadGil2 (2020), 0 descendants of its own
- K032684: Raycell (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K865027
Methodology: https://510kreport.com/methodology