De Novo · Granted
GrantedNeurostar TMS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuronetics · OBP Transcranial Magnetic Stimulator
Granted on Oct 7, 2008 as a new device type through De Novo after a 502-day review. 85 later devices descend from it.
- Decided
- Oct 7, 2008
- Review
- 502 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
85 later devices descend from it, 6 citing it directly.
- This deviceDEN070003 Neurostar TMS SystemNeuronetics · 2008
- Descendant · cites it directly · 84 of its ownK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- Descendant · cites it directly · 78 of its ownK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- Descendant · cites it directly · 77 of its ownK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- Descendant · 2 generations on · 62 of its ownK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- Descendant · 2 generations on · 57 of its ownK150641 MagVita TMS Therapy SystemTonica Elektronik A/S · 2015
Showing 5 of 85 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 85 · See all- K083538Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · cites it directly84descendants
- K130233Neurostar TMS Therapy SystemNeuronetics · 2013 · cites it directly78descendants
- K133408Neurostar TMS Therapy SystemNeuronetics · 2014 · cites it directly77descendants
- K143531Rapid Therapy SystemMagstim Company Limited · 2015 · 2 generations on62descendants
- K150641MagVita TMS Therapy SystemTonica Elektronik A/S · 2015 · 2 generations on57descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| +1 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| +1 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| +1 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| +2 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| +2 | K150641 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 8 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 8 | 0 |
| 2023 | 13 | 0 |
| 2024 | 6 | 0 |
| 2025 | 14 | 0 |
| 2026 | 10 | 0 |
Sources: FDA De Novo database (decision fields), 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (85)
See all 856 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083538 | Neurostar TMS Therapy System, Model 1.1 | 2008 | 84 |
| K130233 | Neurostar TMS Therapy System | 2013 | 78 |
| K133408 | Neurostar TMS Therapy System | 2014 | 77 |
| K122288 | Brainsway Deep TMS System | 2013 | 25 |
| K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy… | 2022 | 19 |
| K220127 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar… | 2022 | 16 |
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?
- Of its descendants, K083538 (Neuronetics, 2008) has gone furthest, with 84 descendants of its own.
How does its category compare?
All OBP devicesOBP Transcranial Magnetic Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 | — |
https://510kreport.com/device/DEN070003 · printed Nov 5, 2026
Cite this page
510(k) Report. “DEN070003: Neurostar TMS System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/DEN070003
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026