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 Masimo Corporation, Vioptix, Inc. and Edwards Lifesciences, LLC.