510(k) · Cleared
ClearedMagpro, Models R30 with Magoption, X100, X100 with Magoption
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 Mar 26, 2010 as substantially equivalent to K061645 (Tonica Elektronik A/S, 2006) and 4 other predicates after a 269-day review. Its family tree reaches back 3 generations to 1991. 2 later devices descend from it.
- Decided
- Mar 26, 2010
- Review
- 269 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K905059 (1991). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK905059 High Speed Magnetic StimulatorCadwell Laboratories, Inc. · 1991
- 2 generations backK051864 Magstim RAPID2, Magstim Super RAPID2, Models 3004-000, 3005-00The Magstim Company, Ltd. · 2005 · Recalled
- 1 generation backK061645 Magpro, Model R30Tonica Elektronik A/S · 2006
- This deviceK091940 Magpro, Models R30 with Magoption, X100, X100 with MagoptionTonica Elektronik A/S · 2010
- Descendant · cites it directly · 0 of its ownK192823 Mega-TMSSoterix Medical, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK162873 MEP MonitorTonica Elektronik A/S · 2017
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 |
|---|---|---|---|---|---|
| −3 | K905059 | High Speed Magnetic Stimulator | Cadwell Laboratories, Inc. | 1991 | — |
| −2 | 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 | — |
| 0 (this device) | K091940 | Magpro, Models R30 with Magoption, X100, X100 with Magoption | Tonica Elektronik A/S | 2010 | — |
| +1 | 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 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 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? (5)
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 |
|---|---|---|---|
| * | K061645 | Magpro, Model R30Summary page 1…MagPro XI100 incl. MagOption Classification name: Evoked Response Electrical Stimulator Identification of predicate devices: MagPro R30, K061645 MagPro, K926516 Magstim Super Rapid 2 , KO051864… | 2006 |
| * | K926516 | Dantec Magnetic Stimulator MagproSummary page 1…name: Evoked Response Electrical Stimulator Identification of predicate devices: MagPro R30, K061645 MagPro, K926516 Magstim Super Rapid 2 , KO051864 Keypoint (K944547)… | 1993 |
| * | K051864 | Magstim RAPID2, Magstim Super RAPID2, Models 3004-000, 3005-00Summary page 1…ation of predicate devices: MagPro R30, K061645 MagPro, K926516 Magstim Super Rapid 2 , KO051864 Keypoint (K944547) Digitimer DS7A (KO5 1357) === P… | 2005 |
| * | K944547 | Dantec KeypointSummary page 1…MagPro, K926516 Magstim Super Rapid 2 , KO051864 Keypoint (K944547) Digitimer DS7A (KO5 1357)… | 1995 |
| * | K051357 | DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant Current High… | 2005 |
What descends from it? (2)
2 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 19 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K192823 (Soterix Medical, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K061645.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 devices are intended to be used for stimulation of peripheral nerves for diagnostic purposes.
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/K091940 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091940: Magpro, Models R30 with Magoption, X100, X100 with Magoption.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091940
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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