510(k) Report

FDA applicant

Med-Tek Innovations, Inc.

Milwaukee, WI3 decisions1991–19940 recalls

FDA records 3 decisions for Med-Tek Innovations, Inc. (Milwaukee, WI) from 1991 to 1994: 3 510(k) clearances. Most are in product codes BYG (Mask, Oxygen) and BYD (Condenser, Heat And Moisture (Artificial Nose)). 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, anesthesiology panel, where it files most

How often FDA has decided Med-Tek Innovations, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Med-Tek Innovations, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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