510(k) · Cleared
ClearedRadGil2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R3 X-Ray L.L.C · MOT Irradiator, Blood To Prevent Graft Versus Host Disease
Cleared on Aug 17, 2020 as substantially equivalent to K172087 (Hitachi, Ltd., 2017) after a 108-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- Aug 17, 2020
- Review
- 108 days
- Class
- Class U
- Product code
- MOT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K865027 (1987). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK865027 Irradiator for Biological Materials, Ibl-137CCis-Us, Inc. · 1987
- 3 generations backK974210 Shielded Cabinet X-Ray Radiation Source Device Model RS 3000Rad-Source, Inc. · 1998 · Recalled
- 2 generations backK082921 Rad Source X-Ray Blood Irradiator, Model RS-3400Rad Source Technologies, Inc. · 2009
- 1 generation backK172087 SangrayHitachi, Ltd. · 2017
- This deviceK201177 RadGil2R3 X-Ray L.L.C · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K865027 | Irradiator for Biological Materials, Ibl-137C | Cis-Us, Inc. | 1987 | — |
| −3 | K974210 | Shielded Cabinet X-Ray Radiation Source Device Model RS 3000 | Rad-Source, Inc. | 1998 | 1 |
| −2 | K082921 | Rad Source X-Ray Blood Irradiator, Model RS-3400 | Rad Source Technologies, Inc. | 2009 | — |
| −1 | K172087 | Sangray | Hitachi, Ltd. | 2017 | — |
| 0 (this device) | K201177 | RadGil2 | R3 X-Ray L.L.C | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K172087 | SangraySummary page 4…mon Name RadGil2 US Classification Name: Blood irradiators have not been classified Legally Marketed Predicate Device SANGRAY (K172087) Device Class: None Product Code MOT Description The RADGIL 2 US x-ray blood i… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 5 companies; a new generation was cleared every 10.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
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. 2020, 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?
RadGil2 US is an X-Ray irradiation device intended for use in the irradiation of blood and blood products packaged in
transfusion bags to inactivate lymphocytes for the prevention of graft vs host disease (GVHD)
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/K201177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201177: RadGil2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201177
Report an extraction error
Are you the manufacturer?
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