510(k) · Cleared
ClearedGammacell 3000 Elan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nordion International, Inc. · MOT Irradiator, Blood To Prevent Graft Versus Host Disease
Cleared on Aug 25, 1995 after a 101-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.
- Decided
- Aug 25, 1995
- Review
- 101 days
- Class
- Class U
- Product code
- MOT
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK952291 Gammacell 3000 ElanNordion International, Inc. · 1995
- Descendant · cites it directly · 1 of its ownK963497 Gammacell 3000 Elan, Version 1.0 and Gammacell 1000 Elite, Version 1.0Nordion International, Inc. · 1996
- Descendant · 2 generations on · 0 of its ownK050963 Gammacell 1000 Elite and Gammacell 3000 ElanMds Nordion · 2005
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 |
|---|---|---|---|---|---|
| 0 (this device) | K952291 | Gammacell 3000 Elan | Nordion International, Inc. | 1995 | — |
| +1 | K963497 | Gammacell 3000 Elan, Version 1.0 and Gammacell 1000 Elite, Version 1.0 | Nordion International, Inc. | 1996 | — |
| +2 | K050963 | Gammacell 1000 Elite and Gammacell 3000 Elan | Mds Nordion | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 |
|---|---|---|---|
| K963497 | Gammacell 3000 Elan, Version 1.0 and Gammacell 1000 Elite, Version 1.0 | 1996 | 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?
- Of its descendants, K963497 (Nordion International, Inc., 1996) has gone furthest, with 1 descendant 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 | — |
https://510kreport.com/device/K952291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K952291: Gammacell 3000 Elan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952291
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026