FDA applicant

Optima Neuroscience, Inc.

Newberry, FL2 decisions2009–20150 recalls

FDA records 2 decisions for Optima Neuroscience, Inc. (Newberry, FL) from 2009 to 2015: 2 510(k) clearances. All are in product code OMB (Automatic Event Detection Software For…). Its devices cite 2 predicates, 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, last Nov 3, 2026

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

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

FDA decisions per year

1in 2015

2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

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

Planning a device like Optima Neuroscience, Inc.’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

Other applicant names beginning “Optima”

FDA records each applicant name separately; these may or may not be the same firm.

Optima Health Solutions International, Inc. 3

Optima Neuroscience, 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?

Other applicant names beginning “Optima”