What Is It?
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.
How Is DXQ Classified?
Blood Pressure Cuff is FDA product code DXQ, Class 2, 21 CFR 870.1120.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 49 clearances under this code; the FDA took a median of 97 days from receipt to decision on them.
One went the Special 510(k) route, the one for a change to the applicant’s own cleared device. 3 were reviewed by an accredited third party.
What Has Gone Wrong With It?
The FDA has recorded 27 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Device Design (6), Labeling Change Control (1) and Process control (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.