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 Aug 26, 2022 as substantially equivalent to K210201 (Brainsway, Ltd., 2021) after a 158-day review. Its family tree reaches back 5 generations to 2008. 2 later devices descend from it.
- Decided
- Aug 26, 2022
- Review
- 158 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN070003 (2008). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 4 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 3 generations backK122288 Brainsway Deep TMS SystemBrainsway, Ltd. · 2013
- 2 generations backK173540 Brainsway Deep (DTMS) SystemBrainsway, Ltd. · 2018
- 1 generation backK210201 Deep Transcranial Magnetic Stimulation (DTMS) SystemBrainsway, Ltd. · 2021
- This deviceK220819 BrainsWay Deep TMS SystemBrainsway, Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK243319 Ampa One System (AMPA-001)Neuromodulatory Devices & Applications · 2025
- Descendant · 2 generations on · 0 of its ownK251210 Ampa One System (AMPA-001)Neuromodulatory Devices & Applications · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −4 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −3 | K122288 | Brainsway Deep TMS System | Brainsway, Ltd. | 2013 | — |
| −2 | K173540 | Brainsway Deep (DTMS) System | Brainsway, Ltd. | 2018 | — |
| −1 | K210201 | Deep Transcranial Magnetic Stimulation (DTMS) System | Brainsway, Ltd. | 2021 | — |
| 0 (this device) | K220819 | BrainsWay Deep TMS System | Brainsway, Ltd. | 2022 | — |
| +1 | K243319 | Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications | 2025 | — |
| +2 | K251210 | Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K210201 | Deep Transcranial Magnetic Stimulation (DTMS) SystemSummary page 4…Device Predicate Device: The subject device is substantially equivalent to the BrainsWay Deep TMSTM Systems (Model 102 and 104) (“predicate device”) cleared in 510(k) K210201 and to the reference predicate devices, the BrainsWay Deep TMSTM Systems, DEN170078 and K183303. Predicate De… | 2021 |
| † | DEN170078 | Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System | 2018 |
| † | K183303 | Brainsway Deep TMS System | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243319 | Ampa One System (AMPA-001) | 2025 | 1 |
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 2 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K243319 (Neuromodulatory Devices & Applications, 2025) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K210201.
How does its category compare?
All OBP devicesOBP Transcranial Magnetic Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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/K220819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220819: BrainsWay Deep TMS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220819
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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