510(k) Report

FDA applicant

Cone Instruments, Inc.

Solon, OH4 decisions1983–19960 recalls

FDA records 4 decisions for Cone Instruments, Inc. (Solon, OH) from 1983 to 1996: 4 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and LLZ (System, Image Processing, Radiological). Its devices cite 1 predicate, 0 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, last Nov 3, 2026

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

How often FDA has decided Cone Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cone Instruments, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Cone”

FDA records each applicant name separately; these may or may not be the same firm.