DeviceClearance

Product code DXO— Cardiovascular

OptoMonitor 3

Classification name
Transducer, Pressure, Catheter Tip
Device class
Class 2
Regulation
21 CFR 870.2870
Advisory panel
Cardiovascular
Total cleared
64
First cleared
Most recent

Market context for product code DXO

FDA has cleared 64 devices under product code DXO between 1979 and 2026, filed by 35 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 DXO

Adverse events under product code DXO

product code DXO
Death
10
Injury
156
Malfunction
884
Total
1,050

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 DXO

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