510(k) · Cleared
ClearedNeuroStar Advanced Therapy System (Version 3.7)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuronetics · OBP Transcranial Magnetic Stimulator
Cleared on Apr 4, 2023 as substantially equivalent to K083538 (Neuronetics, 2008) and 7 other predicates after a 90-day review. Its family tree reaches back 10 generations to 2008. 13 later devices descend from it.
- Decided
- Apr 4, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 10 generations to DEN070003 (2008). 23 ancestors in all. 13 later devices descend from it, 4 citing it directly.
- Root · 10 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 6 generations between
- 3 generations backK173620 Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 2018
- 2 generations backK193006 MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS…Tonica Elektronik A/S · 2020
- 1 generation backK212289 NeuroStar Advanced Therapy for adjunctive treatment of OCD…Neuronetics, Inc. · 2022
- This deviceK230029 NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023
- Descendant · cites it directly · 7 of its ownK231926 NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc. · 2024 · Recalled
- Descendant · cites it directly · 3 of its ownK251119 MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025
- Descendant · 2 generations on · 1 of its ownK243700 Apollo TMS Therapy SystemMag & More GmbH · 2025
- Descendant · 2 generations on · 1 of its ownK251125 MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025
- Descendant · 2 generations on · 1 of its ownK243869 Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0…The Magstim Company Limited · 2025
Show all 10 generations
- Root · 10 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 9 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 8 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 7 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 6 generations backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- 5 generations backK160309 Neurosoft TMSTeleemg, LLC · 2016
- 4 generations backK171967 MagVita TMS Therapy SystemTonica Elektronik A/S · 2017
- 3 generations backK173620 Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 2018
- 2 generations backK193006 MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS…Tonica Elektronik A/S · 2020
- 1 generation backK212289 NeuroStar Advanced Therapy for adjunctive treatment of OCD…Neuronetics, Inc. · 2022
- This deviceK230029 NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K231926NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc. · 2024 · cites it directly7descendants
- K251119MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025 · cites it directly3descendants
- K243700Apollo TMS Therapy SystemMag & More GmbH · 2025 · 2 generations on1descendant
- K251125MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025 · 2 generations on1descendant
- K243869Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System…The Magstim Company Limited · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −9 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −8 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −7 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −6 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| −5 | K160309 | Neurosoft TMS | Teleemg, LLC | 2016 | — |
| −4 | K171967 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2017 | — |
| −3 | K173620 | Mag Vita TMS Therapy System w/Theta Burst Stimulation | Tonica Elektronik A/S | 2018 | — |
| −2 | K193006 | MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system | Tonica Elektronik A/S | 2020 | — |
| −1 | K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced… | Neuronetics, Inc. | 2022 | — |
| 0 (this device) | K230029 | NeuroStar Advanced Therapy System (Version 3.7) | Neuronetics | 2023 | — |
| +1 | K231926 | NeuroStar Advanced Therapy System (All previously cleared models) | Neuronetics, Inc. | 2024 | 1 |
| +1 | K251119 | MagVenture TMS Therapy System | Tonica Elektronik A/S | 2025 | — |
| +2 | K243700 | Apollo TMS Therapy System | Mag & More GmbH | 2025 | — |
| +2 | K251125 | MagVenture TMS Therapy System | Tonica Elektronik A/S | 2025 | — |
| +2 | K243869 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS… | The Magstim Company Limited | 2025 | — |
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 |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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? (8)
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…Classifications: 21 CFR 882.5805, 21 CFR 882.5802 Product Codes: OBP, QCI Primary Predicate Device: NeuroStar Advanced Therapy System (K083538, K130233, K133408, K160703, K161519, K201158, and K220127) (Product C… | 2008 |
| * | K130233 | Neurostar TMS Therapy SystemSummary page 4…cations: 21 CFR 882.5805, 21 CFR 882.5802 Product Codes: OBP, QCI Primary Predicate Device: NeuroStar Advanced Therapy System (K083538, K130233, K133408, K160703, K161519, K201158, and K220127) (Product Code: OBP)… | 2013 |
| * | K133408 | Neurostar TMS Therapy SystemSummary page 4…21 CFR 882.5802 Product Codes: OBP, QCI Primary Predicate Device: NeuroStar Advanced Therapy System (K083538, K130233, K133408, K160703, K161519, K201158, and K220127) (Product Code: OBP) Secondary Predicate Device: NeuroSt… | 2014 |
| * | K160703 | NeuroStar TMS Therapy SystemSummary page 4…2.5802 Product Codes: OBP, QCI Primary Predicate Device: NeuroStar Advanced Therapy System (K083538, K130233, K133408, K160703, K161519, K201158, and K220127) (Product Code: OBP) Secondary Predicate Device: NeuroStar Advanc… | 2016 |
| * | K161519 | NeuroStar TMS Therapy SystemSummary page 4…roduct Codes: OBP, QCI Primary Predicate Device: NeuroStar Advanced Therapy System (K083538, K130233, K133408, K160703, K161519, K201158, and K220127) (Product Code: OBP) Secondary Predicate Device: NeuroStar Advanced Therap… | 2016 |
| * | K201158 | NeuroStar Advanced TherapySummary page 4…des: OBP, QCI Primary Predicate Device: NeuroStar Advanced Therapy System (K083538, K130233, K133408, K160703, K161519, K201158, and K220127) (Product Code: OBP) Secondary Predicate Device: NeuroStar Advanced Therapy System… | 2020 |
| * | K220127 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar…Summary page 4…OBP, QCI Primary Predicate Device: NeuroStar Advanced Therapy System (K083538, K130233, K133408, K160703, K161519, K201158, and K220127) (Product Code: OBP) Secondary Predicate Device: NeuroStar Advanced Therapy System (K212289) (Pr… | 2022 |
| * | K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy…Summary page 4…K133408, K160703, K161519, K201158, and K220127) (Product Code: OBP) Secondary Predicate Device: NeuroStar Advanced Therapy System (K212289) (Product Code: QCI)… | 2022 |
What descends from it? (13)
See all 134 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 15 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 23 ancestors have a recall of any class.
- Of its descendants, K231926 (Neuronetics, Inc., 2024) has gone furthest, with 7 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. 2023, 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 Advanced Therapy System 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 failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.
The NeuroStar Advanced 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/K230029 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230029: NeuroStar Advanced Therapy System (Version 3.7).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230029
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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