Brainsway , Ltd.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Brainsway , Ltd.” (first 2013, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 158 days. Since 2017 the median was 146 days, against 137 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 161 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 169 |
| 2019 | 1 | 101 |
| 2020 | 1 | 134 |
| 2021 | 3 | 127 |
| 2022 | 1 | 158 |
| 2023 | 0 | — |
| 2024 | 1 | 679 |
| 2025 | 2 | 156 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Brainsway , Ltd. took a median 146 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 137 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OBP | Transcranial Magnetic Stimulator | 8 | 8 |
| QMD | Transcranial Magnetic Stimulation System For Smoking Cessation | 2 | 2 |
| QCI | Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder | 1 | 1 |
Review panels
- Neurology (11)
Most recent Brainsway , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251391 | BrainsWay Deep TMS System | OBP | 2025-11-07 | 186 |
| K251449 | BrainsWay Deep TMS System | OBP | 2025-09-13 | 127 |
| K222196 | Deep TMS System | OBP | 2024-05-31 | 679 |
| K220819 | BrainsWay Deep TMS System | OBP | 2022-08-26 | 158 |
| K210201 | Deep Transcranial Magnetic Stimulation (DTMS) System | OBP | 2021-08-17 | 204 |
| K203735 | Brainsway Deep TMS System | OBP | 2021-04-23 | 123 |
| K203616 | Brainsway Deep (DTMS) System | QMD | 2021-04-16 | 127 |
| K200957 | Brainsway Deep TMS System | QMD | 2020-08-21 | 134 |
| K183303 | Brainsway Deep TMS System | QCI | 2019-03-08 | 101 |
| K173540 | Brainsway Deep (DTMS) System | OBP | 2018-05-03 | 169 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Brainsway , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Brainsway , Ltd. is the lead sponsor of 9 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07216872: Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment of Alcohol Use Disorder (AUD) (Recruiting, started 2025-11-07)
- NCT06357832: New Investigational Stimulation Protocol for Treatment of Major Depression Disorder (MDD) (Completed, started 2024-04-29)
- NCT04679753: Brainsway DTMS for Treatment of MDD Using iTBS (Completed, started 2019-01-01)
- NCT02229903: An Evaluation of the Safety and Efficacy of the dTMS Treatment for OCD (Completed, started 2014-09)
- NCT02126124: Evaluation of Deep Transcranial Magnetic Stimulation (DTMS) With the H-ADD Coil as an Aid to Smoking Cessation. (Completed, started 2014-08-20)
SEC filings
Brainsway Ltd. (BRSYF, BWAY): EDGAR filings, CIK 1505065. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Brainsway , Ltd.?
FDA lists 11 510(k) clearances under the applicant name “Brainsway , Ltd.” (first 2013, latest 2025), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Brainsway , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Brainsway , Ltd. is 158 days. Since 2017: 146 days, versus 137 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Brainsway , Ltd.?
The most frequent FDA product codes under this applicant name are OBP (Transcranial Magnetic Stimulator, 8); QMD (Transcranial Magnetic Stimulation System For Smoking Cessation, 2); QCI (Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder, 1).
Next steps
- See all 11 Brainsway , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OBP, Brainsway , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.