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 Jan 7, 2013 as substantially equivalent to DEN070003 (Neuronetics, 2008) and 1 other predicate after a 161-day review. Its family tree reaches back 2 generations to 2008. 25 later devices descend from it.
- Decided
- Jan 7, 2013
- Review
- 161 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN070003 (2008). 25 later devices descend from it, 3 citing it directly.
- Root · 2 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 1 generation backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- This deviceK122288 Brainsway Deep TMS SystemBrainsway, Ltd. · 2013
- Descendant · cites it directly · 24 of its ownK173540 Brainsway Deep (DTMS) SystemBrainsway, Ltd. · 2018
- Descendant · cites it directly · 22 of its ownK210201 Deep Transcranial Magnetic Stimulation (DTMS) SystemBrainsway, Ltd. · 2021
- Descendant · 2 generations on · 16 of its ownK220127 NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System…Neuronetics, Inc. · 2022
- Descendant · 3 generations on · 13 of its ownK230029 NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023
- Descendant · 4 generations on · 7 of its ownK231926 NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc. · 2024 · Recalled
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K173540Brainsway Deep (DTMS) SystemBrainsway, Ltd. · 2018 · cites it directly24descendants
- K210201Deep Transcranial Magnetic Stimulation (DTMS) SystemBrainsway, Ltd. · 2021 · cites it directly22descendants
- K220127NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar…Neuronetics, Inc. · 2022 · 2 generations on16descendants
- K230029NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023 · 3 generations on13descendants
- K231926NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc. · 2024 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −1 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| 0 (this device) | K122288 | Brainsway Deep TMS System | Brainsway, Ltd. | 2013 | — |
| +1 | K173540 | Brainsway Deep (DTMS) System | Brainsway, Ltd. | 2018 | — |
| +1 | K210201 | Deep Transcranial Magnetic Stimulation (DTMS) System | Brainsway, Ltd. | 2021 | — |
| +2 | K220127 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar… | Neuronetics, Inc. | 2022 | — |
| +3 | K230029 | NeuroStar Advanced Therapy System (Version 3.7) | Neuronetics | 2023 | — |
| +4 | K231926 | NeuroStar Advanced Therapy System (All previously cleared models) | Neuronetics, Inc. | 2024 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | DEN070003 | Neurostar TMS System Our reading of the summary gave K061053, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN070003, Neurostar TMS System (Neuronetics), granted Oct 7, 2008; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2008 |
| * | K083538 | Neurostar TMS Therapy System, Model 1.1Summary page 1…STAR TMS SYSTEM K061053 OBP Neuronetics NEUROSTAR TMS THERAPY K083538 OBP _________SYSTEM, MODEL 1.1 Page 5-2… | 2008 |
What descends from it? (25)
See all 253 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 5 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K173540 (Brainsway, Ltd., 2018) has gone furthest, with 24 descendants of its own.
- 5 other devices also cite its predicate DEN070003.
How does its category compare?
All OBP devicesOBP Transcranial Magnetic Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 as stated in the FDA summary.
https://510kreport.com/device/K122288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122288: 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/K122288
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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