FDA applicant

Brainscope Company, Inc.

Bethesda, MD8 decisions2009–20190 recalls

FDA records 8 decisions for Brainscope Company, Inc. (Bethesda, MD) from 2009 to 2019: 7 510(k) clearances and 1 De Novo grant. Most are in product codes PIW (Brain Injury Adjunctive Interpretive…) and OLT (Non-Normalizing Quantitative…). Its devices cite 13 predicates, 6 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, last Nov 3, 2026

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

How often FDA has decided Brainscope Company, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2009high 2 (2018) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Brainscope Company, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Brainscope Company, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?