510(k) · Cleared
ClearedMEP Monitor
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 31, 2017 as substantially equivalent to K051864 (The Magstim Company, Ltd., 2005) and 2 other predicates after a 169-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Mar 31, 2017
- Review
- 169 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K905059 (1991). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK905059 High Speed Magnetic StimulatorCadwell Laboratories, Inc. · 1991
- 3 generations backK051864 Magstim RAPID2, Magstim Super RAPID2, Models 3004-000, 3005-00The Magstim Company, Ltd. · 2005 · Recalled
- 2 generations backK061645 Magpro, Model R30Tonica Elektronik A/S · 2006
- 1 generation backK091940 Magpro, Models R30 with Magoption, X100, X100 with MagoptionTonica Elektronik A/S · 2010
- This deviceK162873 MEP MonitorTonica Elektronik A/S · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K905059 | High Speed Magnetic Stimulator | Cadwell Laboratories, Inc. | 1991 | — |
| −3 | K051864 | Magstim RAPID2, Magstim Super RAPID2, Models 3004-000, 3005-00 | The Magstim Company, Ltd. | 2005 | 2 |
| −2 | 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 | — |
| 0 (this device) | 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 |
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? (3)
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 |
|---|---|---|---|
| * | K051864 | Magstim RAPID2, Magstim Super RAPID2, Models 3004-000, 3005-00Summary page 4…evice Product Code: GWF Regulation number: 21 CFR 882.1870 Identification of predicate device: MEP POD, Magstim Rapid² in K051864, MagPro magnetic stimulators in K061645 / K091940… | 2005 |
| * | K061645 | Magpro, Model R30Summary page 4…21 CFR 882.1870 Identification of predicate device: MEP POD, Magstim Rapid² in K051864, MagPro magnetic stimulators in K061645 / K091940 510 (k) Summary.doc Rev. 3.0, March 22, 2… | 2006 |
| * | K091940 | Magpro, Models R30 with Magoption, X100, X100 with MagoptionSummary page 4…dicate device: MEP POD, Magstim Rapid² in K051864, MagPro magnetic stimulators in K061645 / K091940 510 (k) Summary.doc Rev. 3.0, March 22, 2017, Page 6- 1 510(k) Traditiona… | 2010 |
| † | K944547 | Dantec Keypoint | 1995 |
| † | K051357 | DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant Current High… | 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 26 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 4 other devices also cite its predicate K051864.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 MEP Monitor is an accessory for the MagPro stimulators (MagPro R30, MagPro R30 including MagOption, MagPro X100, and MagPro X100 including MagOption) and is intended to monitor evoked potentials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162873 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162873: MEP Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162873
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