DeviceClearance

Product code DXQ— Cardiovascular

Aneroid Sphygmomanometer

Classification name
Blood Pressure Cuff
Device class
Class 2
Regulation
21 CFR 870.1120
Advisory panel
Cardiovascular
Total cleared
199
First cleared
Most recent

FDA classification definition

“A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.”

— U.S. Food and Drug Administration, device classification record for product code DXQ under 21 CFR 870.1120, via openFDA

Market context for product code DXQ

FDA has cleared 199 devices under product code DXQ between 1976 and 2026, filed by 138 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 DXQ

Recent clearances under product code DXQ

1–100 of 199

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