FDA applicant
Hc Electronics
FDA records 10 decisions for Hc Electronics (Mchenry, IL) from 1977 to 1981: 10 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and EPF (Hearing Aid, Group And Auditory Trainer). 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 Hc Electronics’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Hc Electronics since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Hc Electronics’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