FDA applicant
Beltone Electronics Corp.
FDA records 42 decisions for Beltone Electronics Corp. (Chicago, IL) from 1980 to 1997: 42 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and EWO (Audiometer). Its devices cite 4 predicates, 3 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 Beltone Electronics Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Beltone Electronics Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Beltone Electronics Corp.’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