FDA applicant
Otodynamics, Ltd.
FDA records 8 decisions for Otodynamics, Ltd. (Crofton, MD) from 1997 to 2024: 8 510(k) clearances. All are in product code EWO (Audiometer). Its devices cite 7 predicates, 5 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Otodynamics”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Otodynamics, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Otodynamics, Ltd.’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