FDA applicant

Kt Medical, Inc.

Mchenry, IL13 decisions1980–19800 recalls

FDA records 13 decisions for Kt Medical, Inc. (Mchenry, IL) in 1980: 13 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and JAF (Monitor, Ultrasonic, Nonfetal). 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 Kt Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kt Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Kt Medical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?