FDA applicant
Telex Communications, Inc.
FDA records 50 decisions for Telex Communications, Inc. (Minneapolis, MN) from 1979 to 1999: 50 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and EPF (Hearing Aid, Group And Auditory Trainer). Its devices cite 5 predicates, 4 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 Telex Communications, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Telex Communications, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Telex Communications, Inc.’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