510(k) · Cleared
Recalled · 2009Neurostar TMS Therapy System, Model 1.1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuronetics · OBP Transcranial Magnetic Stimulator
Cleared on Dec 16, 2008 as substantially equivalent to DEN070003 (Neuronetics, 2008) after an 18-day review. Its family tree reaches back 1 generation to 2008. 84 later devices descend from it. It has been recalled once.
- Decided
- Dec 16, 2008
- Review
- 18 days
- Class
- Class II
- Product code
- OBP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN070003 (2008). 84 later devices descend from it, 9 citing it directly.
- Root · 1 generation backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- This deviceK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008
- 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 · cites it directly · 57 of its ownK150641 MagVita TMS Therapy SystemTonica Elektronik A/S · 2015
- Descendant · 2 generations on · 55 of its ownK160703 NeuroStar TMS Therapy SystemNeuronetics, Inc. · 2016
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 84 · See all- 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 · cites it directly57descendants
- K160703NeuroStar TMS Therapy SystemNeuronetics, Inc. · 2016 · 2 generations on55descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| 0 (this device) | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | — |
| +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 |
| +1 | K150641 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2015 | — |
| +2 | K160703 | NeuroStar TMS Therapy System | Neuronetics, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | DEN070003 | Neurostar TMS System Our reading of the summary gave K061053, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN070003, Neurostar TMS System (Neuronetics), granted Oct 7, 2008; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2008 |
What descends from it? (84)
See all 849 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130233 | Neurostar TMS Therapy System | 2013 | 78 |
| K133408 | Neurostar TMS Therapy System | 2014 | 77 |
| K150641 | MagVita TMS Therapy System | 2015 | 57 |
| 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 |
| K230029 | NeuroStar Advanced Therapy System (Version 3.7) | 2023 | 13 |
| K233621 | NeuroStar Advanced Therapy System (Version 3.8) | 2023 | 1 |
| K222230 | NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar… | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 16, 2009 | Not classified | Z-1421-2009 | Process control | SenStar Treatment Link may have an open circuit that during use with the NeuroStar TMS Therapy system may cause arcing and heat damage to the SenStar and/or treatment coil. Heating of the SenStar during use has a potential risk of minor… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 | — |
What is it indicated for?
The NeuroStar TMS Therapy System is indicated for the treatment of Major Depressive Disorder
in adult patients who have failed to achieve satisfactory improvement from one prior
antidepressant medication at or above the minimal effective dose and duration in the current
episode.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083538: Neurostar TMS Therapy System, Model 1.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083538
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