FDA applicant
Hoffrel Instruments, Inc.
FDA records 12 decisions for Hoffrel Instruments, Inc. (South Norwalk, CT) from 1978 to 1987: 12 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and ITX (Transducer, Ultrasonic, Diagnostic). 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 Hoffrel Instruments, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Hoffrel Instruments, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Hoffrel Instruments, 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