510(k) · Cleared
Recalled · 2002Shielded Cabinet X-Ray Radiation Source Device Model RS 3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rad-Source, Inc. · MOT Irradiator, Blood To Prevent Graft Versus Host Disease
Cleared on Mar 30, 1998 as substantially equivalent to K865027 (Cis-Us, Inc., 1987) after a 140-day review. Its family tree reaches back 1 generation to 1987. 4 later devices descend from it. It has been recalled once.
- Decided
- Mar 30, 1998
- Review
- 140 days
- Class
- Class U
- Product code
- MOT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K865027 (1987). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK865027 Irradiator for Biological Materials, Ibl-137CCis-Us, Inc. · 1987
- This deviceK974210 Shielded Cabinet X-Ray Radiation Source Device Model RS 3000Rad-Source, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK082921 Rad Source X-Ray Blood Irradiator, Model RS-3400Rad Source Technologies, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK172087 SangrayHitachi, Ltd. · 2017
- Descendant · 3 generations on · 0 of its ownK201177 RadGil2R3 X-Ray L.L.C · 2020
- Descendant · cites it directly · 0 of its ownK032684 RaycellMds Nordion · 2003
Most influential descendants
Showing 4 of 4 · See all- K082921Rad Source X-Ray Blood Irradiator, Model RS-3400Rad Source Technologies, Inc. · 2009 · cites it directly2descendants
- K172087SangrayHitachi, Ltd. · 2017 · 2 generations on1descendant
- K201177RadGil2R3 X-Ray L.L.C · 2020 · 3 generations on0descendants
- K032684RaycellMds Nordion · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K865027 | Irradiator for Biological Materials, Ibl-137C | Cis-Us, Inc. | 1987 | — |
| 0 (this device) | K974210 | Shielded Cabinet X-Ray Radiation Source Device Model RS 3000 | Rad-Source, Inc. | 1998 | — |
| +1 | K082921 | Rad Source X-Ray Blood Irradiator, Model RS-3400 | Rad Source Technologies, Inc. | 2009 | — |
| +2 | K172087 | Sangray | Hitachi, Ltd. | 2017 | — |
| +3 | K201177 | RadGil2 | R3 X-Ray L.L.C | 2020 | — |
| +1 | K032684 | Raycell | Mds Nordion | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K865027 | Irradiator for Biological Materials, Ibl-137CSummary page 1…President Device Trade Name: RS 3000 sShielded Cabinet X-ray Radiation Source. Common Name: blood irradiator. Classification: not classified. Predicate Device: IBL 437C (K865027) manufactured by CIS-US, Inc. 10 DeAngelo Drive Bedford, Massachusetts 01730 Description of Device: The RS 3000 Shielded Cabin… | 1987 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 1, 2002 | Not classified | Z-0745-04 | Other | The firm completed a cooling system retrofit to preclude overheating and failure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K082921 (Rad Source Technologies, Inc., 2009) has gone furthest, with 2 descendants of its own.
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.
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?
The RS 3000 Shielded Cabinet X-ray Radiation Source is 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974210: Shielded Cabinet X-Ray Radiation Source Device Model RS 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974210
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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