510(k) · Cleared
ClearedNeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuronetics, Inc. · OBP Transcranial Magnetic Stimulator
Cleared on Jul 15, 2022 as substantially equivalent to K210201 (Brainsway, Ltd., 2021) and 7 other predicates after a 178-day review. Its family tree reaches back 7 generations to 2008. 16 later devices descend from it.
- Decided
- Jul 15, 2022
- Review
- 178 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 7 generations to DEN070003 (2008). 10 ancestors in all. 16 later devices descend from it, 5 citing it directly.
- Root · 7 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 6 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 5 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 4 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 3 generations backK160703 NeuroStar TMS Therapy SystemNeuronetics, Inc. · 2016
- 2 generations backK161519 NeuroStar TMS Therapy SystemNeuronetics, Inc. · 2016
- 1 generation backK201158 NeuroStar Advanced TherapyNeuronetics, Inc. · 2020
- This deviceK220127 NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System…Neuronetics, Inc. · 2022
- Descendant · cites it directly · 13 of its ownK230029 NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023
- Descendant · 2 generations on · 7 of its ownK231926 NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc. · 2024 · Recalled
- Descendant · 2 generations on · 3 of its ownK251119 MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025
- Descendant · 3 generations on · 1 of its ownK243700 Apollo TMS Therapy SystemMag & More GmbH · 2025
- Descendant · 3 generations on · 1 of its ownK251125 MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K230029NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023 · cites it directly13descendants
- K231926NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc. · 2024 · 2 generations on7descendants
- K251119MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025 · 2 generations on3descendants
- K243700Apollo TMS Therapy SystemMag & More GmbH · 2025 · 3 generations on1descendant
- K251125MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −6 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −5 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −4 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −3 | K160703 | NeuroStar TMS Therapy System | Neuronetics, Inc. | 2016 | — |
| −2 | K161519 | NeuroStar TMS Therapy System | Neuronetics, Inc. | 2016 | — |
| −1 | K201158 | NeuroStar Advanced Therapy | Neuronetics, Inc. | 2020 | — |
| 0 (this device) | K220127 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar… | Neuronetics, Inc. | 2022 | — |
| +1 | K230029 | NeuroStar Advanced Therapy System (Version 3.7) | Neuronetics | 2023 | — |
| +2 | K231926 | NeuroStar Advanced Therapy System (All previously cleared models) | Neuronetics, Inc. | 2024 | 1 |
| +2 | K251119 | MagVenture TMS Therapy System | Tonica Elektronik A/S | 2025 | — |
| +3 | K243700 | Apollo TMS Therapy System | Mag & More GmbH | 2025 | — |
| +3 | K251125 | MagVenture TMS Therapy System | Tonica Elektronik A/S | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 4 | 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? (9)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K210201 | Deep Transcranial Magnetic Stimulation (DTMS) SystemSummary page 4…ation: 21 CFR 882.5805 Product Code: OBP Predicate Devices: Primary Predicate: Brainsway Deep Transcranial Magnetic Stimulation (K210201) Predicate: NeuroStar Advanced Therapy System (K201158, K161519, K160703, K133408, K1… | 2021 |
| * | K201158 | NeuroStar Advanced TherapySummary page 4…Primary Predicate: Brainsway Deep Transcranial Magnetic Stimulation (K210201) Predicate: NeuroStar Advanced Therapy System (K201158, K161519, K160703, K133408, K130233, K083538) Page 1 of 13 ===… | 2020 |
| * | K161519 | NeuroStar TMS Therapy SystemSummary page 4…Predicate: Brainsway Deep Transcranial Magnetic Stimulation (K210201) Predicate: NeuroStar Advanced Therapy System (K201158, K161519, K160703, K133408, K130233, K083538) Page 1 of 13 === Page 5 =… | 2016 |
| * | K160703 | NeuroStar TMS Therapy SystemSummary page 4…scranial Magnetic Stimulation (K210201) Predicate: NeuroStar Advanced Therapy System (K201158, K161519, K160703, K133408, K130233, K083538) Page 1 of 13… | 2016 |
| * | K133408 | Neurostar TMS Therapy SystemSummary page 4…Magnetic Stimulation (K210201) Predicate: NeuroStar Advanced Therapy System (K201158, K161519, K160703, K133408, K130233, K083538) Page 1 of 13… | 2014 |
| * | K130233 | Neurostar TMS Therapy SystemSummary page 4…Stimulation (K210201) Predicate: NeuroStar Advanced Therapy System (K201158, K161519, K160703, K133408, K130233, K083538) Page 1 of 13… | 2013 |
| * | K083538 | Neurostar TMS Therapy System, Model 1.1Summary page 4…on (K210201) Predicate: NeuroStar Advanced Therapy System (K201158, K161519, K160703, K133408, K130233, K083538) Page 1 of 13 510k Sum… | 2008 |
| * | 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 |
| Kept off the family tree | DEN060153 | NeuroStar Advanced Therapy System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 6…ivalent to the FDA-cleared Brainsway Deep TMS (K210201). • The predicate device, NeuroStar Advanced Therapy System, was previously cleared by the FDA under DEN060153/K061053, K083538, K130233 and K133408, K160703, K160703, K161519, and K201158. • The subject device changes remain… |
What descends from it? (16)
See all 165 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230029 | NeuroStar Advanced Therapy System (Version 3.7) | 2023 | 13 |
| K233621 | NeuroStar Advanced Therapy System (Version 3.8) | 2023 | 1 |
| K260560 | Apollo TMS Therapy System;Apollo light TMS Therapy System | 2026 | 0 |
| K223154 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon… | 2023 | 0 |
| K222230 | NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar… | 2022 | 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 14 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K230029 (Neuronetics, 2023) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K210201.
How does its category compare?
All OBP devicesOBP Transcranial Magnetic Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220127: NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220127
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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