Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Brainsway , Ltd. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
158 daysmedian FDA review time
204 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251391 | BrainsWay Deep TMS System | Brainsway , Ltd. | 2025-11-07 | 186 | 0 |
| K251449 | BrainsWay Deep TMS System | Brainsway , Ltd. | 2025-09-13 | 127 | 0 |
| K222196 | Deep TMS System | Brainsway , Ltd. | 2024-05-31 | 679 | 0 |
| K220819 | BrainsWay Deep TMS System | Brainsway , Ltd. | 2022-08-26 | 158 | 0 |
| K210201 | Deep Transcranial Magnetic Stimulation (DTMS) System | Brainsway , Ltd. | 2021-08-17 | 204 | 0 |
| K203735 | Brainsway Deep TMS System | Brainsway , Ltd. | 2021-04-23 | 123 | 0 |
| K203616 | Brainsway Deep (DTMS) System | Brainsway , Ltd. | 2021-04-16 | 127 | 0 |
| K200957 | Brainsway Deep TMS System | Brainsway , Ltd. | 2020-08-21 | 134 | 0 |
| K183303 | Brainsway Deep TMS System | Brainsway , Ltd. | 2019-03-08 | 101 | 0 |
| K173540 | Brainsway Deep (DTMS) System | Brainsway , Ltd. | 2018-05-03 | 169 | 0 |
| K122288 | BRAINSWAY DEEP TMS SYSTEM | Brainsway , Ltd. | 2013-01-07 | 161 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda