FDA Product Code MUD: Oximeter, Tissue Saturation
Under FDA product code MUD, tissue saturation oximeters are cleared for non-invasive regional oxygen saturation monitoring.
These devices use near-infrared spectroscopy to measure the oxygen saturation of hemoglobin in tissue — typically the brain or somatic tissue — rather than in arterial blood alone. They are used during cardiac surgery, carotid endarterectomy, and critical care to detect regional tissue ischemia.
MUD devices are Class II medical devices, regulated under 21 CFR 870.2700 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Edwards Lifesciences, LLC, Masimo Corporation and Covidien, LLC.
List of Oximeter, Tissue Saturation devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Oximeter, Tissue Saturation devices (product code MUD). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →