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. · QMD Transcranial Magnetic Stimulation System For Smoking Cessation
Cleared on Aug 21, 2020 as substantially equivalent to DEN170078 (Brainways, Ltd., 2018) after a 134-day review. Its family tree reaches back 1 generation to 2018. 1 later device descends from it.
- Decided
- Aug 21, 2020
- Review
- 134 days
- Class
- Class II
- Product code
- QMD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170078 (2018). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K203616Brainsway Deep (DTMS) SystemBrainsway, Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170078 | Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System | Brainways, Ltd. | 2018 | — |
| 0 (this device) | K200957 | Brainsway Deep TMS System | Brainsway, Ltd. | 2020 | — |
| +1 | K203616 | Brainsway Deep (DTMS) System | Brainsway, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 QMD? 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 QMD device
- #1 K203616 Brainsway Deep (DTMS) Systemscore 1.5 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | DEN170078 | Brainsway Deep Transcranial Magnetic Stimulation (DTMS) SystemSummary page 5…following predicate devices: Predicate Manufacturer De Novo No. Brainsway Ltd. Brainsway Deep TMS System DEN170078 Device Description: The Brainsway Deep TMS System enables direct non-invasive activation of deep brain structure… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203616 | Brainsway Deep (DTMS) System | 2021 | 0 |
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?
How does its category compare?
All QMD devicesQMD Transcranial Magnetic Stimulation System For Smoking Cessation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QMD
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · QMD
Too few QMD 510(k)s in any year since 2007 to give a median.
Recalls per year · QMD
No recall names QMD since 2007.
Adverse event reports per year · QMD
No MAUDE report names QMD since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Brainsway Deep Transcranial Magnetic Stimulation System is indicated to be used as an aid in short-term smoking cessation for adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200957: 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/K200957
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