FDA Product Code DXQ: Blood Pressure Cuff

Blood pressure measurement depends on accurate, well-fitting cuffs. FDA product code DXQ covers blood pressure cuffs used with sphygmomanometers for indirect blood pressure measurement.

These inflatable cuffs are wrapped around the arm or thigh and inflated to occlude the brachial or popliteal artery, with controlled deflation allowing assessment of systolic and diastolic pressure. Correct cuff sizing is critical to measurement accuracy.

DXQ devices are Class II medical devices, regulated under 21 CFR 870.1120 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Ge Medical Systems Information Technologies, Inc., Avita Corporation and Baxter Healthcare Corporation.