FDA applicant
Medisono, LLC
FDA records 3 decisions for Medisono, LLC (Wilmington, DE) from 2017 to 2024: 3 510(k) clearances. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Since 2016 its 510(k)s took a median of 128 days from receipt to decision, against 83 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Medisono”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medisono, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Medisono, 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