FDA applicant
Brainsway, Ltd.
FDA records 11 decisions for Brainsway, Ltd. (Jerusalem, IL) from 2013 to 2025: 11 510(k) clearances. Most are in product codes OBP (Transcranial Magnetic Stimulator) and QMD (Transcranial Magnetic Stimulation System For…). Since 2016 its 510(k)s took a median of 169 days from receipt to decision, against 132 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 10 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Brainsway, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like Brainsway, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report