FDA applicant
Brainz Instruments, Ltd.
FDA records 3 decisions for Brainz Instruments, Ltd. (Auckland, NZ) from 2003 to 2007: 3 510(k) clearances. Most are in product codes OLT (Non-Normalizing Quantitative…) and OMA (Amplitude-Integrated Electroencephalograph). Its devices cite 10 predicates, 3 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 Brainz Instruments, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2007
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Brainz Instruments, 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