DeviceClearance

Product code DRS— Cardiovascular

DISPOSABLE DIAPHRAGM DOMES

Classification name
Transducer, Blood-Pressure, Extravascular
Device class
Class 2
Regulation
21 CFR 870.2850
Advisory panel
Cardiovascular
Total cleared
149
First cleared
Most recent

Market context for product code DRS

FDA has cleared 149 devices under product code DRS between 1977 and 2026, filed by 82 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 DRS

Adverse events under product code DRS

product code DRS
Death
8
Malfunction
776
Total
784

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 DRS

1–100 of 149

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