FDA applicant
Fine-Tune
FDA records 4 decisions for Fine-Tune (Deltona, FL) in 1986: 4 510(k) clearances. All are in product code ESD (Hearing Aid, Air-Conduction, Prescription). 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 Fine-Tune’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Fine-Tune since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Fine-Tune’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) ReportOther applicant names beginning “Fine-Tune”
FDA records each applicant name separately; these may or may not be the same firm.