FDA applicant
Cortical Dynamics, Ltd.
FDA records 1 decision for Cortical Dynamics, Ltd. (North Perth, AU) in 2023: 1 510(k) clearance. All are in product code OLW (Index-Generating Electroencephalograph Software). Its devices cite 1 predicate, 0 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 Cortical Dynamics, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Cortical Dynamics, 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