510(k) · Cleared
ClearedGammacell 3000 Elan, Version 1.0 and Gammacell 1000 Elite, Version 1.0
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 Nov 8, 1996 as substantially equivalent to K952291 (Nordion International, Inc., 1995) after a 66-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Nov 8, 1996
- Review
- 66 days
- Class
- Class U
- Product code
- MOT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952291 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK952291 Gammacell 3000 ElanNordion International, Inc. · 1995
- This deviceK963497 Gammacell 3000 Elan, Version 1.0 and Gammacell 1000 Elite, Version 1.0Nordion International, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK050963 Gammacell 1000 Elite and Gammacell 3000 ElanMds Nordion · 2005
Most influential descendants
Showing 1 of 1 · See all- K050963Gammacell 1000 Elite and Gammacell 3000 ElanMds Nordion · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952291 | Gammacell 3000 Elan | Nordion International, Inc. | 1995 | — |
| 0 (this device) | K963497 | Gammacell 3000 Elan, Version 1.0 and Gammacell 1000 Elite, Version 1.0 | Nordion International, Inc. | 1996 | — |
| +1 | K050963 | Gammacell 1000 Elite and Gammacell 3000 Elan | Mds Nordion | 2005 | — |
Descendants 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.
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 |
|---|---|---|---|
| * | K952291 | Gammacell 3000 ElanSummary page 1…ion 1.0 Gammacell 1000 ELITE, Version 1.0 3. Legally Marketed Device: Gammacell 3000 Elan, Version 2.09 Gammacel!l 1000 Elite, Version 2.09 File Number of Last 510(k): K952291 447 March Road, Kanata. Ontario. Canada K2K 15(8 Tel.: (613) 592-2790 Fax: (613) 592-6937 4. Product description… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050963 | Gammacell 1000 Elite and Gammacell 3000 Elan | 2005 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K050963 (Mds Nordion, 2005) has gone furthest, with 0 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 intended use of the modified Gammacell with version 1.0 control system remains unchanged. Both the improved and the predicate device effectively irradiate blood and blood components to inactivate leukocytes and lymphocytes.
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/K963497 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963497: Gammacell 3000 Elan, Version 1.0 and Gammacell 1000 Elite, Version 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963497
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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