# K082921: Rad Source X-Ray Blood Irradiator, Model RS-3400

- Pathway: 510(k) (Traditional)
- Applicant: Rad Source Technologies, Inc.
- Decided: Feb 17, 2009 after 139 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 K865027 (1987). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974210: Shielded Cabinet X-Ray Radiation Source Device Model RS 3000, Rad-Source, Inc. (1998) Summary page 1.

## Most influential descendants
- K172087: Sangray (2017), 1 descendant of its own
- K201177: RadGil2 (2020), 0 descendants of its own

## Indications for use
Intended for the -irradiation of blood or blood products packaged in transfusion bags in accordance with "Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products" (22 July 1993 memorandum from Acting Director, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA to all registered blood establishments) when irradiation to reduce the risk of Graft Versus Host Disease is indicated.

Source page: https://510kreport.com/device/K082921
Methodology: https://510kreport.com/methodology