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 Apr 23, 2021 as substantially equivalent to K173620 (Tonica Elektronik A/S, 2018) and 2 other predicates after a 123-day review. Its family tree reaches back 8 generations to 2008.
- Decided
- Apr 23, 2021
- Review
- 123 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to DEN070003 (2008). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 7 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 6 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 5 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 4 generations backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- 3 generations backK160309 Neurosoft TMSTeleemg, LLC · 2016
- 2 generations backK171967 MagVita TMS Therapy SystemTonica Elektronik A/S · 2017
- 1 generation backK173620 Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 2018
- This deviceK203735 Brainsway Deep TMS SystemBrainsway, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −7 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −6 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −5 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −4 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| −3 | K160309 | Neurosoft TMS | Teleemg, LLC | 2016 | — |
| −2 | K171967 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2017 | — |
| −1 | K173620 | Mag Vita TMS Therapy System w/Theta Burst Stimulation | Tonica Elektronik A/S | 2018 | — |
| 0 (this device) | K203735 | Brainsway Deep TMS System | Brainsway, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 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? (3)
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 |
|---|---|---|---|
| * | K173620 | Mag Vita TMS Therapy System w/Theta Burst StimulationSummary page 4…ion of the iTBS stimulation protocol is substantially equivalent to the MagVita TMS Therapy System w/ Theta Burst Stimulation (Tonica Elektronik A/S, cleared in 510(k) K173620 ("main" predicate device). Predicate Device Manufacturer 510(k) Main Ma… | 2018 |
| * | K122288 | Brainsway Deep TMS SystemSummary page 4…s II Medical Device Predicate Device: The subject device is a modification of the BrainsWay Deep TMS System (“reference" predicate device) that was cleared in 510(k) K122288 and the BrainsWay Deep TMS System cleared in 510(k) K173540 (“reference" predicate device). The inclusion of the iTBS stimulati… | 2013 |
| * | K173540 | Brainsway Deep (DTMS) SystemSummary page 4…s a modification of the BrainsWay Deep TMS System (“reference" predicate device) that was cleared in 510(k) K122288 and the BrainsWay Deep TMS System cleared in 510(k) K173540 (“reference" predicate device). The inclusion of the iTBS stimulation protocol is substantially equivalent to the MagVita TMS Th… | 2018 |
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 13 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 15 ancestors have a recall of any class.
- 8 other devices also cite its predicate K173620.
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 in adult patients suffering from
Major Depressive Disorder who failed to achieve satisfactory improvement from previous anti-depressant 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/K203735 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203735: Brainsway Deep TMS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203735
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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