FDA applicant

Cyberkinetics, Inc.

Foxboro, MA2 decisions2005–20060 recalls

FDA records 2 decisions for Cyberkinetics, Inc. (Foxboro, MA) from 2005 to 2006: 2 510(k) clearances. Most are in product codes GWQ (Full-Montage Standard Electroencephalograph) and OMC (Reduced- Montage Standard Electroencephalograph). Its devices cite 1 predicate, 1 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 Cyberkinetics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cyberkinetics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cyberkinetics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Cyberkinetics”

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

Cyberkinetics, Inc. (Cki) 1 Cyberkinetics Neurotechnology Systems, Inc. 1

Cyberkinetics, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Cyberkinetics”