510(k) · Cleared
ClearedRad Source X-Ray Blood Irradiator, Model RS-3400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rad Source Technologies, Inc. · MOT Irradiator, Blood To Prevent Graft Versus Host Disease
Cleared on Feb 17, 2009 as substantially equivalent to K974210 (Rad-Source, Inc., 1998) after a 139-day review. Its family tree reaches back 2 generations to 1987. 2 later devices descend from it.
- Decided
- Feb 17, 2009
- Review
- 139 days
- Class
- Class U
- Product code
- MOT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K865027 (1987). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK865027 Irradiator for Biological Materials, Ibl-137CCis-Us, Inc. · 1987
- 1 generation backK974210 Shielded Cabinet X-Ray Radiation Source Device Model RS 3000Rad-Source, Inc. · 1998 · Recalled
- This deviceK082921 Rad Source X-Ray Blood Irradiator, Model RS-3400Rad Source Technologies, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK172087 SangrayHitachi, Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK201177 RadGil2R3 X-Ray L.L.C · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K865027 | Irradiator for Biological Materials, Ibl-137C | Cis-Us, Inc. | 1987 | — |
| −1 | K974210 | Shielded Cabinet X-Ray Radiation Source Device Model RS 3000 | Rad-Source, Inc. | 1998 | 1 |
| 0 (this device) | K082921 | Rad Source X-Ray Blood Irradiator, Model RS-3400 | Rad Source Technologies, Inc. | 2009 | — |
| +1 | K172087 | Sangray | Hitachi, Ltd. | 2017 | — |
| +2 | K201177 | RadGil2 | R3 X-Ray L.L.C | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MOT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MOT device
- #1 K201177 RadGil2score 0.8 · 4 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K974210 | Shielded Cabinet X-Ray Radiation Source Device Model RS 3000Summary page 1…name - N/A Predicate=1-evc~e.:_ ________________ RS 3000 Shielded Cabinet X-ray Radiation Souirce, 510(k) numbcr K97421 0, Description of Device: The RS 3400 Rad Source X-ray Blood Irradiator consists of a shielded enclosure containing one x-ray tub… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172087 | Sangray | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 11.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K172087 (Hitachi, Ltd., 2017) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K974210.
How does its category compare?
All MOT devicesMOT Irradiator, Blood To Prevent Graft Versus Host Disease: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MOT
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · MOT
Too few MOT 510(k)s in any year since 2007 to give a median.
Recalls per year · MOT
No recall names MOT since 2007.
Adverse event reports per year · MOT
1in 2014
MAUDE reports naming product code MOT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082921: Rad Source X-Ray Blood Irradiator, Model RS-3400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082921
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026