DeviceClearance

Product code MUD— Cardiovascular

Masimo O3 Regional Oximeter System

Classification name
Oximeter, Tissue Saturation
Device class
Class 2
Regulation
21 CFR 870.2700
Advisory panel
Cardiovascular
Total cleared
74
First cleared
Most recent

Market context for product code MUD

FDA has cleared 74 devices under product code MUD between 1998 and 2026, filed by 24 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code MUD

Adverse events under product code MUD

product code MUD
Malfunction
467
Total
467

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code MUD

Data sourced from openFDA. This site is unofficial and independent of the FDA.