How Is CAI Classified?
Circuit, Breathing (W Connector, Adaptor, Y Piece) is FDA product code CAI, Class 1, 21 CFR 868.5240.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
What Has Gone Wrong With It?
The FDA has recorded 205 recalls under this product code since 2003. None was by a company in China. 20 are Class I, the most serious grade.
The root causes the FDA records most often are Process control (17), Nonconforming Material/Component (7) and Device Design (4). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.