510(k) · Cleared
ClearedOCD MT Cap (85-00397-000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuronetics · QCI Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Cleared on Jun 8, 2023 as substantially equivalent to K212289 (Neuronetics, Inc., 2022) and 1 other predicate after a 30-day review. Its family tree reaches back 11 generations to 2008.
- Decided
- Jun 8, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- QCI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to DEN070003 (2008). 24 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK231350 OCD MT Cap (85-00397-000)Neuronetics · 2023
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 deviceK231350 OCD MT Cap (85-00397-000)Neuronetics · 2023
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) | K231350 | OCD MT Cap (85-00397-000) | Neuronetics | 2023 | — |
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 |
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 K212289 NeuroStar Advanced Therapy for adjunctive…score 17.7 · 9 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 |
|---|---|---|---|
| * | K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy…Summary page 4…mmon Name: Transcranial Magnetic Stimulator Classifications: 21 CFR 882.5802 Product Codes: QCI Predicate Device: NeuroStar Advanced Therapy System (K212289, K230029) (Product Code: QCI) Page… | 2022 |
| * | K230029 | NeuroStar Advanced Therapy System (Version 3.7)Summary page 4…: Transcranial Magnetic Stimulator Classifications: 21 CFR 882.5802 Product Codes: QCI Predicate Device: NeuroStar Advanced Therapy System (K212289, K230029) (Product Code: QCI) Page 1 of 6… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 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.
- 3 other devices also cite its predicate K212289.
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. 2023, 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/K231350 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231350: OCD MT Cap (85-00397-000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231350
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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