DeviceClearance

Product code DXN— Cardiovascular

Electronic Blood Pressure Monitor

Classification name
System, Measurement, Blood-Pressure, Non-Invasive
Device class
Class 2
Regulation
21 CFR 870.1130
Advisory panel
Cardiovascular
Total cleared
1,222
First cleared
Most recent

Market context for product code DXN

FDA has cleared 1,222 devices under product code DXN between 1976 and 2026, filed by 457 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 DXN

Adverse events under product code DXN

product code DXN
Death
3
Injury
169
Malfunction
1,019
Other
2
Total
1,193

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 DXN

1–100 of 1,222

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