510(k) Report

FDA applicant

Cyberkinetics, Inc. (Cki)

Salt Lake City, UT1 decision2005–20052 recalls

FDA records 1 decision for Cyberkinetics, Inc. (Cki) (Salt Lake City, UT) in 2005: 1 510(k) clearance. All are in product code GZL (Electrode, Depth). 2 recalls are 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. (Cki)’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cyberkinetics, Inc. (Cki) since 2007.

Recalls per year

1in 2010

2009: 12010: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cyberkinetics, Inc. (Cki) 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.