510(k) · Cleared
ClearedMagVita 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 Jul 31, 2015 as substantially equivalent to K083538 (Neuronetics, 2008) and 1 other predicate after a 142-day review. Its family tree reaches back 4 generations to 2008. 57 later devices descend from it.
- Decided
- Jul 31, 2015
- Review
- 142 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to DEN070003 (2008). 57 later devices descend from it, 11 citing it directly.
- Root · 4 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 3 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 2 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 1 generation backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- This deviceK150641 MagVita TMS Therapy SystemTonica Elektronik A/S · 2015
- Descendant · cites it directly · 48 of its ownK171481 MagVita TMS Therapy SystemTonica Elektronik A/S · 2017
- Descendant · cites it directly · 46 of its ownK160309 Neurosoft TMSTeleemg, LLC · 2016
- Descendant · cites it directly · 41 of its ownK170114 MagVita TMS Therapy - w/MagPro R20Tonica Elektronik A/S · 2017
- Descendant · 2 generations on · 40 of its ownK172667 MagVita TMS Therapy w/MagPro R20Tonica Elektronik A/S · 2017
- Descendant · cites it directly · 40 of its ownK171967 MagVita TMS Therapy SystemTonica Elektronik A/S · 2017
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K171481MagVita TMS Therapy SystemTonica Elektronik A/S · 2017 · cites it directly48descendants
- K160309Neurosoft TMSTeleemg, LLC · 2016 · cites it directly46descendants
- K170114MagVita TMS Therapy - w/MagPro R20Tonica Elektronik A/S · 2017 · cites it directly41descendants
- K172667MagVita TMS Therapy w/MagPro R20Tonica Elektronik A/S · 2017 · 2 generations on40descendants
- K171967MagVita TMS Therapy SystemTonica Elektronik A/S · 2017 · cites it directly40descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −3 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −2 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −1 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| 0 (this device) | K150641 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2015 | — |
| +1 | K171481 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2017 | — |
| +1 | K160309 | Neurosoft TMS | Teleemg, LLC | 2016 | — |
| +1 | K170114 | MagVita TMS Therapy - w/MagPro R20 | Tonica Elektronik A/S | 2017 | — |
| +2 | K172667 | MagVita TMS Therapy w/MagPro R20 | Tonica Elektronik A/S | 2017 | — |
| +1 | K171967 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 10 | 0 |
| 2024 | 5 | 0 |
| 2025 | 13 | 0 |
| 2026 | 10 | 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? (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 |
|---|---|---|---|
| * | K083538 | Neurostar TMS Therapy System, Model 1.1Summary page 4…21 CFR 882.5805, Product Code OBP] Classification: Class II Medical Device Predicate Device: NeuroStar TMS Therapy Systems (K083538, K133408) 21 CFR 882.5805, Repetitive Transcranial Magnetic Stimulation… | 2008 |
| * | K133408 | Neurostar TMS Therapy SystemSummary page 4…2.5805, Product Code OBP] Classification: Class II Medical Device Predicate Device: NeuroStar TMS Therapy Systems (K083538, K133408) 21 CFR 882.5805, Repetitive Transcranial Magnetic Stimulation… | 2014 |
| † | K061645 | Magpro, Model R30 | 2006 |
| † | K071821 | Coils, Models MCF-B65, MCF-75, MCF-125 and Cool-B65 | 2007 |
| † | K091940 | Magpro, Models R30 with Magoption, X100, X100 with Magoption | 2010 |
What descends from it? (57)
See all 5711 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171481 | MagVita TMS Therapy System | 2017 | 48 |
| K160309 | Neurosoft TMS | 2016 | 46 |
| K170114 | MagVita TMS Therapy - w/MagPro R20 | 2017 | 41 |
| K171967 | MagVita TMS Therapy System | 2017 | 40 |
| K173620 | Mag Vita TMS Therapy System w/Theta Burst Stimulation | 2018 | 39 |
| K193006 | MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system | 2020 | 24 |
| K251125 | MagVenture TMS Therapy System | 2025 | 1 |
| K212723 | BTL-995-rTMS | 2022 | 1 |
| K182768 | TMS-Cobot TS MV | 2019 | 1 |
| K252032 | T65 (9016E061-) | 2025 | 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 7 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K171481 (Tonica Elektronik A/S, 2017) has gone furthest, with 48 descendants of its own.
- 8 other devices also cite its predicate K083538.
How does its category compare?
All OBP devicesOBP Transcranial Magnetic Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
The MagVita TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who
have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150641 · printed Nov 3, 2026
Cite this page
510(k) Report. “K150641: MagVita TMS Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K150641
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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