510(k) · Cleared
Recalled · Class II · 2026NeuroStar Advanced Therapy System (Version 3.8)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuronetics · OBP Transcranial Magnetic Stimulator
Cleared on Dec 13, 2023 as substantially equivalent to K083538 (Neuronetics, 2008) and 8 other predicates after a 30-day review. Its family tree reaches back 11 generations to 2008. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 13, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- OBP
- Recalls
- 1
- Predicates
- 9
Its longest line of descent runs back 11 generations to DEN070003 (2008). 24 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 7 generations between
- 3 generations backK193006 MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS…Tonica Elektronik A/S · 2020
- 2 generations backK212289 NeuroStar Advanced Therapy for adjunctive treatment of OCD…Neuronetics, Inc. · 2022
- 1 generation backK230029 NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023
- This deviceK233621 NeuroStar Advanced Therapy System (Version 3.8)Neuronetics · 2023
- Descendant · cites it directly · 0 of its ownK260691 BTL-699BTL Industries, Inc. · 2026
Show all 11 generations
- Root · 11 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 10 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 9 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 8 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 7 generations backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- 6 generations backK160309 Neurosoft TMSTeleemg, LLC · 2016
- 5 generations backK171967 MagVita TMS Therapy SystemTonica Elektronik A/S · 2017
- 4 generations backK173620 Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 2018
- 3 generations backK193006 MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS…Tonica Elektronik A/S · 2020
- 2 generations backK212289 NeuroStar Advanced Therapy for adjunctive treatment of OCD…Neuronetics, Inc. · 2022
- 1 generation backK230029 NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023
- This deviceK233621 NeuroStar Advanced Therapy System (Version 3.8)Neuronetics · 2023
Most influential descendants
Showing 1 of 1 · See all- K260691BTL-699BTL Industries, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −10 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −9 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −8 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −7 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| −6 | K160309 | Neurosoft TMS | Teleemg, LLC | 2016 | — |
| −5 | K171967 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2017 | — |
| −4 | K173620 | Mag Vita TMS Therapy System w/Theta Burst Stimulation | Tonica Elektronik A/S | 2018 | — |
| −3 | K193006 | MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system | Tonica Elektronik A/S | 2020 | — |
| −2 | K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced… | Neuronetics, Inc. | 2022 | — |
| −1 | K230029 | NeuroStar Advanced Therapy System (Version 3.7) | Neuronetics | 2023 | — |
| 0 (this device) | K233621 | NeuroStar Advanced Therapy System (Version 3.8) | Neuronetics | 2023 | — |
| +1 | K260691 | BTL-699 | BTL Industries, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083538 | Neurostar TMS Therapy System, Model 1.1Summary page 4…Magnetic Stimulator Classifications: 882.5805, 882.5802 Product Codes: OBP, QCI Primary Predicate Device: NeuroStar Advanced Therapy System: K083538, K130233, K133408, K160703, K161519, K201158, K220127, and K230029 (Produ… | 2008 |
| * | K130233 | Neurostar TMS Therapy SystemSummary page 4…Stimulator Classifications: 882.5805, 882.5802 Product Codes: OBP, QCI Primary Predicate Device: NeuroStar Advanced Therapy System: K083538, K130233, K133408, K160703, K161519, K201158, K220127, and K230029 (Product Code:… | 2013 |
| * | K133408 | Neurostar TMS Therapy SystemSummary page 4…882.5805, 882.5802 Product Codes: OBP, QCI Primary Predicate Device: NeuroStar Advanced Therapy System: K083538, K130233, K133408, K160703, K161519, K201158, K220127, and K230029 (Product Code: OBP) Secondary Predicate Neu… | 2014 |
| * | K160703 | NeuroStar TMS Therapy SystemSummary page 4…05, 882.5802 Product Codes: OBP, QCI Primary Predicate Device: NeuroStar Advanced Therapy System: K083538, K130233, K133408, K160703, K161519, K201158, K220127, and K230029 (Product Code: OBP) Secondary Predicate NeuroStar Ad… | 2016 |
| * | K161519 | NeuroStar TMS Therapy SystemSummary page 4…802 Product Codes: OBP, QCI Primary Predicate Device: NeuroStar Advanced Therapy System: K083538, K130233, K133408, K160703, K161519, K201158, K220127, and K230029 (Product Code: OBP) Secondary Predicate NeuroStar Advanced Th… | 2016 |
| * | K201158 | NeuroStar Advanced TherapySummary page 4…uct Codes: OBP, QCI Primary Predicate Device: NeuroStar Advanced Therapy System: K083538, K130233, K133408, K160703, K161519, K201158, K220127, and K230029 (Product Code: OBP) Secondary Predicate NeuroStar Advanced Therapy Sys… | 2020 |
| * | K220127 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar…Summary page 4…: OBP, QCI Primary Predicate Device: NeuroStar Advanced Therapy System: K083538, K130233, K133408, K160703, K161519, K201158, K220127, and K230029 (Product Code: OBP) Secondary Predicate NeuroStar Advanced Therapy System: K212… | 2022 |
| * | K230029 | NeuroStar Advanced Therapy System (Version 3.7)Summary page 4…OBP, QCI Primary Predicate Device: NeuroStar Advanced Therapy System: K083538, K130233, K133408, K160703, K161519, K201158, K220127, and K230029 (Product Code: OBP) Secondary Predicate NeuroStar Advanced Therapy System: K212289 and K2300… | 2023 |
| * | K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy…Summary page 4…K133408, K160703, K161519, K201158, K220127, and K230029 (Product Code: OBP) Secondary Predicate NeuroStar Advanced Therapy System: K212289 and K230029 Device: (Product Code: QCI)… | 2022 |
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 |
|---|---|---|---|
| K260691 | BTL-699 | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 24, 2026 | Class II | Z-0142-2027 | Nonconforming Material/Component | Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 24 ancestors have a recall of any class.
- Of its descendants, K260691 (BTL Industries, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K083538.
How does its category compare?
All OBP devicesOBP Transcranial Magnetic Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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.
The NeuroStar Advanced Therapy system is intended to be used as an adjunct for the treatment of
adult patients suffering from Obsessive-Compulsive Disorder (OCD).
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/K233621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233621: NeuroStar Advanced Therapy System (Version 3.8).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233621
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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