510(k) Report

FDA applicant

Hoffrel Instruments, Inc.

South Norwalk, CT12 decisions1978–19870 recalls

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, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

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.

FIG. 1 — Hoffrel Instruments, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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