FDA applicant

Oculogica, Inc.

New York, NY6 decisions2018–20260 recalls

FDA records 6 decisions for Oculogica, Inc. (New York, NY) from 2018 to 2026: 5 510(k) clearances and 1 De Novo grant. All are in product code QEA (Brain Injury Adjunctive Interpretive…). Its devices cite 6 predicates, 5 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 Oculogica, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2018high 1 (2018) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Oculogica, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Oculogica, 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?