FDA applicant
Embolic Acceleration, LLC
FDA records 1 decision for Embolic Acceleration, LLC (Miami, FL) in 2020: 1 510(k) clearance. All are in product code KRD (Device, Vascular, For Promoting Embolization). Its devices cite 1 predicate, 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
How often FDA has decided Embolic Acceleration, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Embolic Acceleration, LLC’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