510(k) · Cleared
ClearedNeuroStar Advanced Therapy
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 Nov 20, 2020 as substantially equivalent to K161519 (Neuronetics, Inc., 2016) after a 204-day review. Its family tree reaches back 6 generations to 2008. 24 later devices descend from it.
- Decided
- Nov 20, 2020
- Review
- 204 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN070003 (2008). 24 later devices descend from it, 6 citing it directly.
- Root · 6 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 5 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 4 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 3 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 2 generations backK160703 NeuroStar TMS Therapy SystemNeuronetics, Inc. · 2016
- 1 generation backK161519 NeuroStar TMS Therapy SystemNeuronetics, Inc. · 2016
- This deviceK201158 NeuroStar Advanced TherapyNeuronetics, Inc. · 2020
- Descendant · cites it directly · 19 of its ownK212289 NeuroStar Advanced Therapy for adjunctive treatment of OCD…Neuronetics, Inc. · 2022
- Descendant · cites it directly · 16 of its ownK220127 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 · 4 of its ownK222171 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon…Magstim Company, Ltd. · 2023
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy…Neuronetics, Inc. · 2022 · cites it directly19descendants
- K220127NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar…Neuronetics, Inc. · 2022 · cites it directly16descendants
- 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
- K222171Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon…Magstim Company, Ltd. · 2023 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −5 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −4 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −3 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −2 | K160703 | NeuroStar TMS Therapy System | Neuronetics, Inc. | 2016 | — |
| −1 | K161519 | NeuroStar TMS Therapy System | Neuronetics, Inc. | 2016 | — |
| 0 (this device) | K201158 | NeuroStar Advanced Therapy | Neuronetics, Inc. | 2020 | — |
| +1 | K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced… | Neuronetics, Inc. | 2022 | — |
| +1 | 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 | K222171 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0… | Magstim Company, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K161519 | NeuroStar TMS Therapy SystemSummary page 5…ic Stimulation Device 21 CFR 882.5805, Product Code OBP Predicate Device: NeuroStar Advanced Therapy System (K161519) Reference Device: MagVita TMS Therapy System w/ Theta Burst Stimulation (K173620) Device Des… | 2016 |
| † | K173620 | Mag Vita TMS Therapy System w/Theta Burst Stimulation | 2018 |
What descends from it? (24)
See all 246 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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 |
| K213543 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar… | 2021 | 1 |
| 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 12 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K212289 (Neuronetics, Inc., 2022) has gone furthest, with 19 descendants of its own.
- 6 other devices also cite its predicate K161519.
How does its category compare?
All OBP devicesOBP Transcranial Magnetic Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
NeuroStar Advanced Therapy 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/K201158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201158: NeuroStar Advanced Therapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201158
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