510(k) · Cleared
ClearedNeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuronetics, Inc. · QCI Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Cleared on May 6, 2022 as substantially equivalent to K193006 (Tonica Elektronik A/S, 2020) and 7 other predicates after a 289-day review. Its family tree reaches back 9 generations to 2008. 19 later devices descend from it.
- Decided
- May 6, 2022
- Review
- 289 days
- Class
- Class II
- Product code
- QCI
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 9 generations to DEN070003 (2008). 18 ancestors in all. 19 later devices descend from it, 4 citing it directly.
- Root · 9 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 5 generations between
- 3 generations backK171967 MagVita TMS Therapy SystemTonica Elektronik A/S · 2017
- 2 generations backK173620 Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 2018
- 1 generation backK193006 MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS…Tonica Elektronik A/S · 2020
- This deviceK212289 NeuroStar Advanced Therapy for adjunctive treatment of OCD…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 · cites it directly · 4 of its ownK222171 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon…Magstim Company, Ltd. · 2023
- Descendant · 2 generations on · 3 of its ownK251119 MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025
- Descendant · 2 generations on · 2 of its ownK232235 Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System…The Magstim Company, Ltd. · 2023
Show all 9 generations
- Root · 9 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 8 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 7 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 6 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 5 generations backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- 4 generations backK160309 Neurosoft TMSTeleemg, LLC · 2016
- 3 generations backK171967 MagVita TMS Therapy SystemTonica Elektronik A/S · 2017
- 2 generations backK173620 Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 2018
- 1 generation backK193006 MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS…Tonica Elektronik A/S · 2020
- This deviceK212289 NeuroStar Advanced Therapy for adjunctive treatment of OCD…Neuronetics, Inc. · 2022
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- 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 · cites it directly4descendants
- K251119MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025 · 2 generations on3descendants
- K232235Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0…The Magstim Company, Ltd. · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −8 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −7 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −6 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −5 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| −4 | K160309 | Neurosoft TMS | Teleemg, LLC | 2016 | — |
| −3 | K171967 | 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 | K193006 | MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system | Tonica Elektronik A/S | 2020 | — |
| 0 (this device) | 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 | — |
| +2 | K231926 | NeuroStar Advanced Therapy System (All previously cleared models) | Neuronetics, Inc. | 2024 | 1 |
| +1 | K222171 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0… | Magstim Company, Ltd. | 2023 | — |
| +2 | K251119 | MagVenture TMS Therapy System | Tonica Elektronik A/S | 2025 | — |
| +2 | K232235 | Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0… | The Magstim Company, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 5 | 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 QCI? 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 QCI device
- #1 K193006 MagVenture TMS Therapy – for treatment of OCD…score 13.9 · 8 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K193006 | MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy systemSummary page 4…CFR 882.5802 Product Code: QCI Predicate Devices: Primary Predicate: MagVenture TMS Therapy System – for adjunctive treatment of OCD (K193006) Predicate: NeuroStar Advanced Therapy System (K201158, K161519, K160703, K133408, K1… | 2020 |
| * | K201158 | NeuroStar Advanced TherapySummary page 4…cate: MagVenture TMS Therapy System – for adjunctive treatment of OCD (K193006) Predicate: NeuroStar Advanced Therapy System (K201158, K161519, K160703, K133408, K130233, K083538, DEN060153/K061053)… | 2020 |
| * | K161519 | NeuroStar TMS Therapy SystemSummary page 4…Venture TMS Therapy System – for adjunctive treatment of OCD (K193006) Predicate: NeuroStar Advanced Therapy System (K201158, K161519, K160703, K133408, K130233, K083538, DEN060153/K061053) Page 1… | 2016 |
| * | K160703 | NeuroStar TMS Therapy SystemSummary page 4…r adjunctive treatment of OCD (K193006) Predicate: NeuroStar Advanced Therapy System (K201158, K161519, K160703, K133408, K130233, K083538, DEN060153/K061053) Page 1 of 7… | 2016 |
| * | K133408 | Neurostar TMS Therapy SystemSummary page 4…ive treatment of OCD (K193006) Predicate: NeuroStar Advanced Therapy System (K201158, K161519, K160703, K133408, K130233, K083538, DEN060153/K061053) Page 1 of 7… | 2014 |
| * | K130233 | Neurostar TMS Therapy SystemSummary page 4…treatment of OCD (K193006) Predicate: NeuroStar Advanced Therapy System (K201158, K161519, K160703, K133408, K130233, K083538, DEN060153/K061053) Page 1 of 7… | 2013 |
| * | K083538 | Neurostar TMS Therapy System, Model 1.1Summary page 4…treatment of OCD (K193006) Predicate: NeuroStar Advanced Therapy System (K201158, K161519, K160703, K133408, K130233, K083538, DEN060153/K061053) Page 1 of 7… | 2008 |
| Kept off the family tree | DEN060153 | NeuroStar Advanced Therapy System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 4…reatment of OCD (K193006) Predicate: NeuroStar Advanced Therapy System (K201158, K161519, K160703, K133408, K130233, K083538, DEN060153/K061053) Page 1 of 7 510k… | |
| * | DEN070003 | Neurostar TMS System Our reading of the summary gave K061053, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN070003, Neurostar TMS System (Neuronetics), granted Oct 7, 2008; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2008 |
What descends from it? (19)
See all 194 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K230029 (Neuronetics, 2023) has gone furthest, with 13 descendants of its own.
- 3 other devices also cite its predicate K193006.
How does its category compare?
All QCI devicesQCI Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QCI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QCI
30in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QCI
No recall names QCI since 2007.
Adverse event reports per year · QCI
2in 2024
MAUDE reports naming product code QCI, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 3 | 30 | 0 | 0 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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 as stated in the FDA summary.
https://510kreport.com/device/K212289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212289: NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212289
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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