510(k) · Cleared
ClearedCoils, Models MCF-B65, MCF-75, MCF-125 and Cool-B65
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 Jul 27, 2007 as substantially equivalent to K061645 (Tonica Elektronik A/S, 2006) after a 24-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Jul 27, 2007
- Review
- 24 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K905059 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK071821 Coils, Models MCF-B65, MCF-75, MCF-125 and Cool-B65Tonica Elektronik A/S · 2007
View 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) | K071821 | Coils, Models MCF-B65, MCF-75, MCF-125 and Cool-B65 | Tonica Elektronik A/S | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 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? (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 |
|---|---|---|---|
| * | K061645 | Magpro, Model R30Summary page 1…MCF-B365, MCF-75, MCF-125, Cool-B365 Classification name: Evoked Response Electrical Stimulator Identification of predicate devices: K061645: MC-125, MC-B370, C-lOG, C-B360, MMC- 140-11 Surnmary~doc… | 2006 |
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 16 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 1 of the 5 ancestors has a recall of any class.
- 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. 2007, 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 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/K071821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071821: Coils, Models MCF-B65, MCF-75, MCF-125 and Cool-B65.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071821
Report an extraction error
Are you the manufacturer?
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