Cleared Special

Optima Coil System (OptiOne Coil System)

K254221 · Balt USA, LLC · Neurology
Jan 2026
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K254221 is an FDA 510(k) clearance for the Optima Coil System (OptiOne Coil System), a Device, Neurovascular Embolization (Class II — Special Controls, product code HCG), submitted by Balt USA, LLC (Irvine, US). The FDA issued a Cleared decision on January 27, 2026, 29 days after receiving the submission on December 29, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.

Submission Details

510(k) Number K254221 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2025
Decision Date January 27, 2026
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HCG — Device, Neurovascular Embolization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5950

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