510(k) · Cleared
ClearedGammacell 1000 Elite and Gammacell 3000 Elan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mds Nordion · MOT Irradiator, Blood To Prevent Graft Versus Host Disease
Cleared on May 20, 2005 as substantially equivalent to K963497 (Nordion International, Inc., 1996) after a 32-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- May 20, 2005
- Review
- 32 days
- Class
- Class U
- Product code
- MOT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K952291 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K963497 | Gammacell 3000 Elan, Version 1.0 and Gammacell 1000 Elite, Version 1.0Summary page 1…al Characteristics The Gammacell 1000 Elite and Gammacell 3000 Elan are substantially equivalent to the previous versions of the Gammacell 1000E and 3000E (k963497). The design change is to replace an obsolete PCB, which is programmed with embedded firmware, with a standard PC 1… | 1996 |
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 10 years and passes through 2 companies; a new generation was cleared every 8.5 years on median.
- None of the 2 ancestors has a recall.
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?
To irradiate cellular blood products to inactivate T-lymphocytes in order to prevent graft
versus host disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050963 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050963: Gammacell 1000 Elite and 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/K050963
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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