510(k) · Cleared
ClearedNeuroStar TMS Therapy System
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 Sep 11, 2016 as substantially equivalent to K133408 (Neuronetics, 2014) and 1 other predicate after a 101-day review. Its family tree reaches back 5 generations to 2008. 27 later devices descend from it.
- Decided
- Sep 11, 2016
- Review
- 101 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to DEN070003 (2008). 27 later devices descend from it, 7 citing it directly.
- Root · 5 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 4 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 3 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 2 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 1 generation backK160703 NeuroStar TMS Therapy SystemNeuronetics, Inc. · 2016
- This deviceK161519 NeuroStar TMS Therapy SystemNeuronetics, Inc. · 2016
- Descendant · cites it directly · 24 of its ownK201158 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
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K201158NeuroStar Advanced TherapyNeuronetics, Inc. · 2020 · cites it directly24descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −4 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −3 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −2 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −1 | K160703 | NeuroStar TMS Therapy System | Neuronetics, Inc. | 2016 | — |
| 0 (this device) | K161519 | NeuroStar TMS Therapy System | Neuronetics, Inc. | 2016 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K133408 | Neurostar TMS Therapy SystemSummary page 4…c Stimulator for Treatment of Major Name: Depressive Disorder [21 CFR 882.5805, Product Code OBP] Predicate Device: NeuroStar TMS Therapy® System [K133408] Device Description: The NeuroStar TMS Therapy System is a computerized, electromechanical medical device that produces and de… | 2014 |
| * | K160703 | NeuroStar TMS Therapy System Cleared while this submission was under review Summary page 5…cteristics and Substantial Equivalence: The NeuroStar TMS Therapy System 3.0 is substantially equivalent to the predicate device (NeuroStar TMS Therapy System, K133408, K160703) for: Indication for Use Principles of Operation Design for Delivery of Transcranial Magnetic Stimulation… | 2016 |
What descends from it? (27)
See all 277 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201158 | NeuroStar Advanced Therapy | 2020 | 24 |
| 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 |
| K180313 | Apollo TMS Therapy System | 2018 | 4 |
| 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)
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 8 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K201158 (Neuronetics, Inc., 2020) has gone furthest, with 24 descendants of its own.
- 8 other devices also cite its predicate K133408.
How does its category compare?
All OBP devicesOBP Transcranial Magnetic Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 receive satisfactory improvement from prior antidepressant medication in the current episode.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161519: NeuroStar TMS Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161519
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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