510(k) Report

FDA applicant

Medical Innovations International, Inc.

Rochester, MN1 decision1990–19900 recalls

FDA records 1 decision for Medical Innovations International, Inc. (Rochester, MN) in 1990: 1 510(k) clearance. All are in product code KAC (Tube, Laryngectomy). 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, ear, nose and throat panel, where it files most

How often FDA has decided Medical Innovations International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Innovations International, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medical Innovations International, 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