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 Vioptix, Inc..
FDA 510(k) Cleared Oximeter, Tissue Saturation Devices (Product Code MUD)
About Product Code MUD - Regulatory Context
510(k) Submission Activity
73 total 510(k) submissions under product code MUD since 1998, with 73 receiving FDA clearance (average review time: 153 days).
Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.
FDA Review Time
Recent submissions under MUD have taken an average of 181 days to reach a decision - up from 152 days historically. Manufacturers should account for longer review timelines in current project planning.
MUD devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →