510(k) · Cleared
ClearedMagVenture TMS Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tonica Elektronik A/S · OBP Transcranial Magnetic Stimulator
Cleared on Aug 11, 2025 as substantially equivalent to K231926 (Neuronetics, Inc., 2024) and 6 other predicates after a 122-day review. Its family tree reaches back 12 generations to 2008. 1 later device descends from it.
- Decided
- Aug 11, 2025
- Review
- 122 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 12 generations to DEN070003 (2008). 25 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 8 generations between
- 3 generations backK212289 NeuroStar Advanced Therapy for adjunctive treatment of OCD…Neuronetics, Inc. · 2022
- 2 generations backK230029 NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023
- 1 generation backK231926 NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc. · 2024 · Recalled
- This deviceK251125 MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025
- Descendant · cites it directly · 0 of its ownK260691 BTL-699BTL Industries, Inc. · 2026
Show all 12 generations
- Root · 12 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 11 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 10 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 9 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 8 generations backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- 7 generations backK160309 Neurosoft TMSTeleemg, LLC · 2016
- 6 generations backK171967 MagVita TMS Therapy SystemTonica Elektronik A/S · 2017
- 5 generations backK173620 Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 2018
- 4 generations backK193006 MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS…Tonica Elektronik A/S · 2020
- 3 generations backK212289 NeuroStar Advanced Therapy for adjunctive treatment of OCD…Neuronetics, Inc. · 2022
- 2 generations backK230029 NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023
- 1 generation backK231926 NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc. · 2024 · Recalled
- This deviceK251125 MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025
Most influential descendants
Showing 1 of 1 · See all- K260691BTL-699BTL Industries, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −11 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −10 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −9 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −8 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| −7 | K160309 | Neurosoft TMS | Teleemg, LLC | 2016 | — |
| −6 | K171967 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2017 | — |
| −5 | K173620 | Mag Vita TMS Therapy System w/Theta Burst Stimulation | Tonica Elektronik A/S | 2018 | — |
| −4 | K193006 | MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system | Tonica Elektronik A/S | 2020 | — |
| −3 | K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced… | Neuronetics, Inc. | 2022 | — |
| −2 | K230029 | NeuroStar Advanced Therapy System (Version 3.7) | Neuronetics | 2023 | — |
| −1 | K231926 | NeuroStar Advanced Therapy System (All previously cleared models) | Neuronetics, Inc. | 2024 | 1 |
| 0 (this device) | K251125 | MagVenture TMS Therapy System | Tonica Elektronik A/S | 2025 | — |
| +1 | K260691 | BTL-699 | BTL Industries, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 OBP? 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 OBP device
- #1 K251119 MagVenture TMS Therapy Systemscore 21.8 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K231926 | NeuroStar Advanced Therapy System (All previously cleared models)Summary page 5…OBP III. PRIMARY PREDICATE DEVICE Predicate Manufacturer: Neuronetics Inc. Predicate Trade Name: NeuroStar Advanced Therapy System Predicate 510(k): K231926 Predicate Regulation: 21 CFR 882.5805 Predicate Regulatory Class: Class II Predicate Device Panel: Neurology Predicate… | 2024 |
| * | K150641 | MagVita TMS Therapy SystemSummary page 6…REDICATE DEVICE Predicate Manufacturer: Tonica Elektronik A/S Predicate Trade Name: MagVita TMS Therapy System Predicate 510(k): K150641, K170114, K171481, K171967, K172667, K173620 Predicate Regulation: 21 CFR 882.5805 Predicate Regulatory Class:… | 2015 |
| * | K170114 | MagVita TMS Therapy - w/MagPro R20Summary page 6…DEVICE Predicate Manufacturer: Tonica Elektronik A/S Predicate Trade Name: MagVita TMS Therapy System Predicate 510(k): K150641, K170114, K171481, K171967, K172667, K173620 Predicate Regulation: 21 CFR 882.5805 Predicate Regulatory Class: Class I… | 2017 |
| * | K171481 | MagVita TMS Therapy SystemSummary page 6…edicate Manufacturer: Tonica Elektronik A/S Predicate Trade Name: MagVita TMS Therapy System Predicate 510(k): K150641, K170114, K171481, K171967, K172667, K173620 Predicate Regulation: 21 CFR 882.5805 Predicate Regulatory Class: Class II Predica… | 2017 |
| * | K171967 | MagVita TMS Therapy SystemSummary page 6…anufacturer: Tonica Elektronik A/S Predicate Trade Name: MagVita TMS Therapy System Predicate 510(k): K150641, K170114, K171481, K171967, K172667, K173620 Predicate Regulation: 21 CFR 882.5805 Predicate Regulatory Class: Class II Predicate Device… | 2017 |
| * | K172667 | MagVita TMS Therapy w/MagPro R20Summary page 6…er: Tonica Elektronik A/S Predicate Trade Name: MagVita TMS Therapy System Predicate 510(k): K150641, K170114, K171481, K171967, K172667, K173620 Predicate Regulation: 21 CFR 882.5805 Predicate Regulatory Class: Class II Predicate Device Panel:… | 2017 |
| * | K173620 | Mag Vita TMS Therapy System w/Theta Burst StimulationSummary page 6…Tonica Elektronik A/S Predicate Trade Name: MagVita TMS Therapy System Predicate 510(k): K150641, K170114, K171481, K171967, K172667, K173620 Predicate Regulation: 21 CFR 882.5805 Predicate Regulatory Class: Class II Predicate Device Panel:… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260691 | BTL-699 | 2026 | 0 |
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 17 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 25 ancestors have a recall of any class.
- Of its descendants, K260691 (BTL Industries, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K231926.
How does its category compare?
All OBP devicesOBP Transcranial Magnetic Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OBP
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBP
125in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBP
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OBP
81in 2025
MAUDE reports naming product code OBP, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 3 | 101 | 0 | 6 |
| 2017 | 8 | 73 | 0 | 3 |
| 2018 | 4 | 144 | 1 | 6 |
| 2019 | 3 | 156 | 0 | 12 |
| 2020 | 1 | — | 0 | 12 |
| 2021 | 5 | 132 | 0 | 15 |
| 2022 | 6 | 168 | 0 | 59 |
| 2023 | 7 | 119 | 0 | 43 |
| 2024 | 5 | 266 | 0 | 50 |
| 2025 | 12 | 125 | 0 | 81 |
| 2026 | 8 | 176 | 1 | — |
What is it indicated for?
MagVenture TMS Therapy System is indicated as an adjunct for the treatment of Major Depressive Disorder in adolescent patients (age 15-21).
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/K251125 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251125: MagVenture TMS Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251125
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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