510(k) · Cleared
ClearedBrainsway Deep (DTMS) 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 Apr 16, 2021 as substantially equivalent to K200957 (Brainsway, Ltd., 2020) after a 127-day review. Its family tree reaches back 2 generations to 2018.
- Decided
- Apr 16, 2021
- Review
- 127 days
- Class
- Class II
- Product code
- QMD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170078 (2018). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 K200957 Brainsway Deep TMS Systemscore 2.9 · 1 generation · 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 |
|---|---|---|---|
| * | K200957 | Brainsway Deep TMS SystemSummary page 5…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. K200957. Similar modifications have been made to the Brainsway Deep TMS System cleared in K183303 (“reference device”). Predicate… | 2020 |
| † | K183303 | Brainsway Deep TMS System | 2019 |
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 3 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 2 ancestors has a recall.
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. 2021, 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/K203616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203616: Brainsway Deep (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/K203616
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