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 8, 2025 as substantially equivalent to K230029 (Neuronetics, 2023) after a 119-day review. Its family tree reaches back 11 generations to 2008. 3 later devices descend from it.
- Decided
- Aug 8, 2025
- Review
- 119 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to DEN070003 (2008). 24 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 11 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 7 generations between
- 3 generations backK193006 MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS…Tonica Elektronik A/S · 2020
- 2 generations backK212289 NeuroStar Advanced Therapy for adjunctive treatment of OCD…Neuronetics, Inc. · 2022
- 1 generation backK230029 NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023
- This deviceK251119 MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025
- Descendant · cites it directly · 0 of its ownK260691 BTL-699BTL Industries, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK260402 MeRT SystemWave Neuroscience · 2026
- Descendant · cites it directly · 0 of its ownK260189 MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/S · 2026
Show all 11 generations
- Root · 11 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 10 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 9 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 8 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 7 generations backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- 6 generations backK160309 Neurosoft TMSTeleemg, LLC · 2016
- 5 generations backK171967 MagVita TMS Therapy SystemTonica Elektronik A/S · 2017
- 4 generations backK173620 Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 2018
- 3 generations backK193006 MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS…Tonica Elektronik A/S · 2020
- 2 generations backK212289 NeuroStar Advanced Therapy for adjunctive treatment of OCD…Neuronetics, Inc. · 2022
- 1 generation backK230029 NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023
- This deviceK251119 MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −10 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −9 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −8 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −7 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| −6 | K160309 | Neurosoft TMS | Teleemg, LLC | 2016 | — |
| −5 | K171967 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2017 | — |
| −4 | K173620 | Mag Vita TMS Therapy System w/Theta Burst Stimulation | Tonica Elektronik A/S | 2018 | — |
| −3 | K193006 | MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system | Tonica Elektronik A/S | 2020 | — |
| −2 | K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced… | Neuronetics, Inc. | 2022 | — |
| −1 | K230029 | NeuroStar Advanced Therapy System (Version 3.7) | Neuronetics | 2023 | — |
| 0 (this device) | K251119 | MagVenture TMS Therapy System | Tonica Elektronik A/S | 2025 | — |
| +1 | K260691 | BTL-699 | BTL Industries, Inc. | 2026 | — |
| +1 | K260402 | MeRT System | Wave Neuroscience | 2026 | — |
| +1 | K260189 | MagVenture Accelerated TMS (aTMS) Therapy System | Tonica Elektronik A/S | 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 | 3 | 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 K220127 NeuroStar TMS Therapy System, NeuroStar…score 20.5 · 7 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 |
|---|---|---|---|
| * | K230029 | NeuroStar Advanced Therapy System (Version 3.7)Summary page 5…III. PREDICATE DEVICE Predicate Manufacturer: Neuronetics Predicate Trade Name: NeuroStar Advanced Therapy System Predicate 510(k): K230029 Predicate Regulation: 21 CFR 882.5805, 21 CFR 882.5802 Predicate Product Code: OBP, QCI… | 2023 |
What descends from it? (3)
3 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 17 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 24 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 K230029.
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 is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
The MagVenture TMS Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251119: MagVenture TMS Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251119
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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