510(k) · Cleared
ClearedMagpro, Model R30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tonica Elektronik A/S · GWF Stimulator, Electrical, Evoked Response
Cleared on Oct 31, 2006 as substantially equivalent to K926516 (Dantec Medical, Inc., 1993) and 1 other predicate after a 141-day review. Its family tree reaches back 2 generations to 1991. 7 later devices descend from it.
- Decided
- Oct 31, 2006
- Review
- 141 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K905059 (1991). 4 ancestors in all. 7 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK905059 High Speed Magnetic StimulatorCadwell Laboratories, Inc. · 1991
- 1 generation backK051864 Magstim RAPID2, Magstim Super RAPID2, Models 3004-000, 3005-00The Magstim Company, Ltd. · 2005 · Recalled
- This deviceK061645 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 · cites it directly · 1 of its ownK160280 MagPro R20Tonica Elektronik A/S · 2016
- Descendant · 2 generations on · 0 of its ownK242345 Delphi StimulatorQuantalx Neuroscience · 2024
- Descendant · 2 generations on · 0 of its ownK192823 Mega-TMSSoterix Medical, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK162873 MEP MonitorTonica Elektronik A/S · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K091940Magpro, Models R30 with Magoption, X100, X100 with MagoptionTonica Elektronik A/S · 2010 · cites it directly2descendants
- K160280MagPro R20Tonica Elektronik A/S · 2016 · cites it directly1descendant
- K242345Delphi StimulatorQuantalx Neuroscience · 2024 · 2 generations on0descendants
- K192823Mega-TMSSoterix Medical, Inc. · 2021 · 2 generations on0descendants
- K162873MEP MonitorTonica Elektronik A/S · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K905059 | High Speed Magnetic Stimulator | Cadwell Laboratories, Inc. | 1991 | — |
| −1 | K051864 | Magstim RAPID2, Magstim Super RAPID2, Models 3004-000, 3005-00 | The Magstim Company, Ltd. | 2005 | 2 |
| 0 (this device) | 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 | — |
| +1 | K160280 | MagPro R20 | Tonica Elektronik A/S | 2016 | — |
| +2 | K242345 | Delphi Stimulator | Quantalx Neuroscience | 2024 | — |
| +2 | K192823 | Mega-TMS | Soterix Medical, Inc. | 2021 | — |
| +1 | K162873 | MEP Monitor | Tonica Elektronik A/S | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 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? (2)
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 |
|---|---|---|---|
| * | K926516 | Dantec Magnetic Stimulator MagproSummary page 1…n name: MagPro R30 Classification name: Evoked Response Electrical Stimulator Identification of predicate devices: MagPro, K9265 16 Magstim Super Rapid', K05 1864 Summary~doc… | 1993 |
| * | K051864 | Magstim RAPID2, Magstim Super RAPID2, Models 3004-000, 3005-00Summary page 1…Evoked Response Electrical Stimulator Identification of predicate devices: MagPro, K9265 16 Magstim Super Rapid', K05 1864 Summary~doc Rev. 2.0, August 31, 2006, Page 5- 1 5 10(k)… | 2005 |
What descends from it? (7)
5 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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 14.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K091940 (Tonica Elektronik A/S, 2010) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K926516.
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 | — |
What is it indicated for?
The device is intended to be used for stimulation of peripheral nerves for diagnostic purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061645 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061645: Magpro, Model R30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061645
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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