510(k) · Cleared
ClearedMagstim Double 70-2 Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Magstim Company, Ltd. · GWF Stimulator, Electrical, Evoked Response
Cleared on Aug 23, 2013 as substantially equivalent to K060847 (Magstim Company Us, LLC, 2006) and 1 other predicate after a 185-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Aug 23, 2013
- Review
- 185 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K905059 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK130403 Magstim Double 70-2 CoilThe Magstim Company, Ltd. · 2013
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) | K130403 | Magstim Double 70-2 Coil | The Magstim Company, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K060847 | Magstim 200-2Summary page 1…eed 24 hours. Predicate Devices This device is substantially equivalent to the current Magstim Model 2002 with Double 70mmn Remote Coil (K060847) and the Magstim Model Rapid2 with Double 70mm Remote Coil (KO51I864). Modifications… | 2006 |
| * | K051864 | Magstim RAPID2, Magstim Super RAPID2, Models 3004-000, 3005-00Summary page 3…redicate Deviee Magstim 2™ Gerieration Double 70mm-Coil P/N 3191-00 (Reference KOGO847) ‘Predicate Device Magstim 2™ Generation Double 70mm Coil P/N 3191-00 (Reference K051864) Intended Use The Magstim D707 coil is a stimulating coil intended for use with the Magstim 200° Stimulating Unit or the Magsti… | 2005 |
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 22 years and passes through 2 companies; a new generation was cleared every 14.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 2 other devices also cite its predicate K060847.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Magstim 0702 Coil is a stimulating coil intended for use with the MagstimO 2002 Stimulating Unit or the Magstim® Rapid 2 Stimulating Unit for the purpose of peripheral nerve stimulation for diagnostic purposes. The coil is an accessory to the Magstim @2002 Stimulating Unit, and the coil is an accessory to the Magstim® Rapid 2 Stimulating Unit.
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/K130403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130403: Magstim Double 70-2 Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130403
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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