510(k) · Cleared
ClearedDeep Transcranial Magnetic Stimulation (DTMS) 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 Aug 17, 2021 as substantially equivalent to K122288 (Brainsway, Ltd., 2013) and 1 other predicate after a 204-day review. Its family tree reaches back 4 generations to 2008. 22 later devices descend from it.
- Decided
- Aug 17, 2021
- Review
- 204 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to DEN070003 (2008). 22 later devices descend from it, 3 citing it directly.
- Root · 4 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 3 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 2 generations backK122288 Brainsway Deep TMS SystemBrainsway, Ltd. · 2013
- 1 generation backK173540 Brainsway Deep (DTMS) SystemBrainsway, Ltd. · 2018
- This deviceK210201 Deep Transcranial Magnetic Stimulation (DTMS) SystemBrainsway, Ltd. · 2021
- Descendant · cites it directly · 16 of its ownK220127 NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System…Neuronetics, Inc. · 2022
- Descendant · 2 generations on · 13 of its ownK230029 NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023
- Descendant · 3 generations on · 7 of its ownK231926 NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc. · 2024 · Recalled
- Descendant · 3 generations on · 3 of its ownK251119 MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025
- Descendant · cites it directly · 2 of its ownK222196 Deep TMS SystemBrainsway, Ltd. · 2024
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K220127NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar…Neuronetics, Inc. · 2022 · cites it directly16descendants
- K230029NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023 · 2 generations on13descendants
- K231926NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc. · 2024 · 3 generations on7descendants
- K251119MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025 · 3 generations on3descendants
- K222196Deep TMS SystemBrainsway, Ltd. · 2024 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −3 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −2 | K122288 | Brainsway Deep TMS System | Brainsway, Ltd. | 2013 | — |
| −1 | K173540 | Brainsway Deep (DTMS) System | Brainsway, Ltd. | 2018 | — |
| 0 (this device) | K210201 | Deep Transcranial Magnetic Stimulation (DTMS) System | Brainsway, Ltd. | 2021 | — |
| +1 | K220127 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar… | Neuronetics, Inc. | 2022 | — |
| +2 | K230029 | NeuroStar Advanced Therapy System (Version 3.7) | Neuronetics | 2023 | — |
| +3 | K231926 | NeuroStar Advanced Therapy System (All previously cleared models) | Neuronetics, Inc. | 2024 | 1 |
| +3 | K251119 | MagVenture TMS Therapy System | Tonica Elektronik A/S | 2025 | — |
| +1 | K222196 | Deep TMS System | Brainsway, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K122288 | Brainsway Deep TMS SystemSummary page 4…II Medical Device Predicate Device: The subject device is a modification of the BrainsWay Deep TMS System (“predicate device”) that was cleared in 510(k) document no. K122288 and the BrainsWay Deep TMS System cleared in K173540 (“reference device”). Predicate Device… | 2013 |
| * | K173540 | Brainsway Deep (DTMS) SystemSummary page 4…vice is a modification of the BrainsWay Deep TMS System (“predicate device”) that was cleared in 510(k) document no. K122288 and the BrainsWay Deep TMS System cleared in K173540 (“reference device”). Predicate Device Manufacturer 510(k) No. Main B… | 2018 |
What descends from it? (22)
See all 223 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 13 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K220127 (Neuronetics, Inc., 2022) has gone furthest, with 16 descendants of its own.
- 2 other devices also cite its predicate K122288.
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 BrainsWay Deep TMS™ 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.
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/K210201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210201: Deep Transcranial Magnetic Stimulation (DTMS) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210201
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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