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 Jun 10, 2016 as substantially equivalent to K133408 (Neuronetics, 2014) after an 88-day review. Its family tree reaches back 4 generations to 2008. 55 later devices descend from it.
- Decided
- Jun 10, 2016
- Review
- 88 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN070003 (2008). 55 later devices descend from it, 8 citing it directly.
- Root · 4 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 3 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 2 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 1 generation backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- This deviceK160703 NeuroStar TMS Therapy SystemNeuronetics, Inc. · 2016
- Descendant · cites it directly · 48 of its ownK171481 MagVita TMS Therapy SystemTonica Elektronik A/S · 2017
- Descendant · 2 generations on · 39 of its ownK173620 Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 2018
- Descendant · cites it directly · 27 of its ownK161519 NeuroStar TMS Therapy SystemNeuronetics, Inc. · 2016
- Descendant · 2 generations on · 24 of its ownK201158 NeuroStar Advanced TherapyNeuronetics, Inc. · 2020
- Descendant · 2 generations on · 24 of its ownK193006 MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS…Tonica Elektronik A/S · 2020
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K171481MagVita TMS Therapy SystemTonica Elektronik A/S · 2017 · cites it directly48descendants
- K173620Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 2018 · 2 generations on39descendants
- K161519NeuroStar TMS Therapy SystemNeuronetics, Inc. · 2016 · cites it directly27descendants
- K201158NeuroStar Advanced TherapyNeuronetics, Inc. · 2020 · 2 generations on24descendants
- K193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy systemTonica Elektronik A/S · 2020 · 2 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −3 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −2 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −1 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| 0 (this device) | K160703 | NeuroStar TMS Therapy System | Neuronetics, Inc. | 2016 | — |
| +1 | K171481 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2017 | — |
| +2 | K173620 | Mag Vita TMS Therapy System w/Theta Burst Stimulation | Tonica Elektronik A/S | 2018 | — |
| +1 | K161519 | NeuroStar TMS Therapy System | Neuronetics, Inc. | 2016 | — |
| +2 | K201158 | NeuroStar Advanced Therapy | Neuronetics, Inc. | 2020 | — |
| +2 | K193006 | MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system | Tonica Elektronik A/S | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 10 | 0 |
| 2024 | 5 | 0 |
| 2025 | 12 | 0 |
| 2026 | 9 | 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 |
|---|---|---|---|
| * | K133408 | Neurostar TMS Therapy SystemSummary page 4…c Stimulator for Treatment of Major 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 |
What descends from it? (55)
See all 558 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171481 | MagVita TMS Therapy System | 2017 | 48 |
| K161519 | NeuroStar TMS Therapy System | 2016 | 27 |
| 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 |
| K180907 | HORIZON TMS Therapy System | 2018 | 12 |
| 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 2.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K171481 (Tonica Elektronik A/S, 2017) has gone furthest, with 48 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/K160703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160703: 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/K160703
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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