510(k) · Cleared
ClearedBrainsWay Deep TMS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainsway, Ltd. · OBP Transcranial Magnetic Stimulator
Cleared on Nov 7, 2025 as substantially equivalent to K222196 (Brainsway, Ltd., 2024) and 1 other predicate after a 186-day review. Its family tree reaches back 12 generations to 2008.
- Decided
- Nov 7, 2025
- Review
- 186 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to DEN070003 (2008). 26 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 8 generations between
- 3 generations backK212289 NeuroStar Advanced Therapy for adjunctive treatment of OCD…Neuronetics, Inc. · 2022
- 2 generations backK230029 NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023
- 1 generation backK231926 NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc. · 2024 · Recalled
- This deviceK251391 BrainsWay Deep TMS SystemBrainsway, Ltd. · 2025
Show all 12 generations
- Root · 12 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 11 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 10 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 9 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 8 generations backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- 7 generations backK160309 Neurosoft TMSTeleemg, LLC · 2016
- 6 generations backK171967 MagVita TMS Therapy SystemTonica Elektronik A/S · 2017
- 5 generations backK173620 Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 2018
- 4 generations backK193006 MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS…Tonica Elektronik A/S · 2020
- 3 generations backK212289 NeuroStar Advanced Therapy for adjunctive treatment of OCD…Neuronetics, Inc. · 2022
- 2 generations backK230029 NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023
- 1 generation backK231926 NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc. · 2024 · Recalled
- This deviceK251391 BrainsWay Deep TMS SystemBrainsway, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −11 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −10 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −9 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −8 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| −7 | K160309 | Neurosoft TMS | Teleemg, LLC | 2016 | — |
| −6 | K171967 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2017 | — |
| −5 | K173620 | Mag Vita TMS Therapy System w/Theta Burst Stimulation | Tonica Elektronik A/S | 2018 | — |
| −4 | K193006 | MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system | Tonica Elektronik A/S | 2020 | — |
| −3 | K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced… | Neuronetics, Inc. | 2022 | — |
| −2 | K230029 | NeuroStar Advanced Therapy System (Version 3.7) | Neuronetics | 2023 | — |
| −1 | K231926 | NeuroStar Advanced Therapy System (All previously cleared models) | Neuronetics, Inc. | 2024 | 1 |
| 0 (this device) | K251391 | BrainsWay Deep TMS System | Brainsway, Ltd. | 2025 | — |
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 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K222196 | Deep TMS SystemSummary page 5…Class II Medical Device Predicate Device: The subject device is a substantially equivalent to the BrainsWay Deep TMSTM Systems (Model 102 and 104) cleared in 510(k) K222196 and to the NeuroStar Advanced Therapy System cleared in 510(k) K231926. Device M… | 2024 |
| * | K231926 | NeuroStar Advanced Therapy System (All previously cleared models)Summary page 5…substantially equivalent to the BrainsWay Deep TMSTM Systems (Model 102 and 104) cleared in 510(k) K222196 and to the NeuroStar Advanced Therapy System cleared in 510(k) K231926. Device Manufacturer 510(k) No. BrainsWay Deep TMSTM System… | 2024 |
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 17 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 26 ancestors have a recall of any class.
- 1 other device also cites its predicate K222196.
How does its category compare?
All OBP devicesOBP Transcranial Magnetic Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 BrainsWay Deep TMS TM 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 BrainsWay Deep TMS TM System is also indicated as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (age 15-21 years).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251391 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251391: BrainsWay Deep TMS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251391
Report an extraction error
Are you the manufacturer?
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