FDA applicant

Braincare Desenvolvimento E Inovacao Tecnologica S.A.

São Carlos, BR3 decisions2019–20240 recalls

FDA records 3 decisions for Braincare Desenvolvimento E Inovacao Tecnologica S.A. (São Carlos, BR) from 2019 to 2024: 3 510(k) clearances. All are in product code GWM (Device, Monitoring, Intracranial Pressure). Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Braincare Desenvolvimento E Inovação Tecnológica S.A.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Braincare Desenvolvimento E Inovacao Tecnologica S.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Braincare Desenvolvimento E Inovacao Tecnologica S.A. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Braincare Desenvolvimento E Inovacao…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Braincare Desenvolvimento E Inovacao Tecnologica S.A.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?