510(k) · Cleared
ClearedDantec Magnetic Stimulator Magpro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dantec Medical, Inc. · GWF Stimulator, Electrical, Evoked Response
Cleared on Aug 31, 1993 after a 244-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Aug 31, 1993
- Review
- 244 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK926516 Dantec Magnetic Stimulator MagproDantec Medical, Inc. · 1993
- Descendant · cites it directly · 10 of its ownK051864 Magstim RAPID2, Magstim Super RAPID2, Models 3004-000, 3005-00The Magstim Company, Ltd. · 2005 · Recalled
- Descendant · cites it directly · 7 of its ownK061645 Magpro, Model R30Tonica Elektronik A/S · 2006
- Descendant · cites it directly · 2 of its ownK091940 Magpro, Models R30 with Magoption, X100, X100 with MagoptionTonica Elektronik A/S · 2010
- Descendant · 2 generations on · 1 of its ownK160280 MagPro R20Tonica Elektronik A/S · 2016
- Descendant · 3 generations on · 0 of its ownK242345 Delphi StimulatorQuantalx Neuroscience · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K051864Magstim RAPID2, Magstim Super RAPID2, Models 3004-000, 3005-00The Magstim Company, Ltd. · 2005 · cites it directly10descendants
- K061645Magpro, Model R30Tonica Elektronik A/S · 2006 · cites it directly7descendants
- K091940Magpro, Models R30 with Magoption, X100, X100 with MagoptionTonica Elektronik A/S · 2010 · cites it directly2descendants
- K160280MagPro R20Tonica Elektronik A/S · 2016 · 2 generations on1descendant
- K242345Delphi StimulatorQuantalx Neuroscience · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K926516 | Dantec Magnetic Stimulator Magpro | Dantec Medical, Inc. | 1993 | — |
| +1 | K051864 | Magstim RAPID2, Magstim Super RAPID2, Models 3004-000, 3005-00 | The Magstim Company, Ltd. | 2005 | 2 |
| +1 | K061645 | Magpro, Model R30 | Tonica Elektronik A/S | 2006 | — |
| +1 | K091940 | Magpro, Models R30 with Magoption, X100, X100 with Magoption | Tonica Elektronik A/S | 2010 | — |
| +2 | K160280 | MagPro R20 | Tonica Elektronik A/S | 2016 | — |
| +3 | K242345 | Delphi Stimulator | Quantalx Neuroscience | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 GWF? 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 GWF device
- #1 K263010 ISIS Headboxes, ISIS Neurostimulator, ISIS…score 17.5 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 113 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K051864 (The Magstim Company, Ltd., 2005) has gone furthest, with 10 descendants of its own.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWF
92in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWF
1,034in 2025
MAUDE reports naming product code GWF, 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 | 3 | 69 | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 5 | 178 | 0 | 1 |
| 2010 | 3 | 269 | 0 | 4 |
| 2011 | 2 | — | 0 | 10 |
| 2012 | 4 | 230 | 1 | 44 |
| 2013 | 3 | 174 | 0 | 89 |
| 2014 | 1 | — | 0 | 25 |
| 2015 | 2 | — | 1 | 22 |
| 2016 | 1 | — | 0 | 20 |
| 2017 | 3 | 169 | 0 | 60 |
| 2018 | 0 | — | 0 | 58 |
| 2019 | 1 | — | 0 | 94 |
| 2020 | 1 | — | 0 | 65 |
| 2021 | 2 | — | 0 | 55 |
| 2022 | 2 | — | 0 | 45 |
| 2023 | 2 | — | 0 | 150 |
| 2024 | 4 | 92 | 0 | 854 |
| 2025 | 1 | — | 0 | 1,034 |
| 2026 | 3 | 125 | 2 | — |
https://510kreport.com/device/K926516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K926516: Dantec Magnetic Stimulator Magpro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926516
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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