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 Dec 10, 2021 as substantially equivalent to K201158 (Neuronetics, Inc., 2020) after a 32-day review. Its family tree reaches back 7 generations to 2008. 1 later device descends from it.
- Decided
- Dec 10, 2021
- Review
- 32 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to DEN070003 (2008). 1 later device descends from it, 1 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 deviceK213543 NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System…Neuronetics, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK222230 NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy…Neuronetics, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K222230NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar…Neuronetics, Inc. · 2022 · cites it directly0descendants
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) | K213543 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar… | Neuronetics, Inc. | 2021 | — |
| +1 | K222230 | NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System… | Neuronetics, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 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 |
|---|---|---|---|
| * | K201158 | NeuroStar Advanced TherapySummary page 4…nd Conditions Regulatory Class: Class II Medical Device Product Code: OBP Predicate Device(s): NeuroStar Advanced Therapy System, K201158, Neuronetics, Inc. / 3222 Phoenixville Pike, Malvern, PA 19355 T 610.640.4202 / F 610.640.4… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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 13 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K222230 (Neuronetics, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K201158.
How does its category compare?
All OBP devicesOBP Transcranial Magnetic Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Major Depressive Disorder in adult patients
who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213543 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213543: 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 4, 2026. https://510kreport.com/device/K213543
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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