Generator, Oxygen, Portable

What Is FDA Product Code CAW?

Generator, Oxygen, Portable is FDA product code CAW, Class 2, 21 CFR 868.5440.

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 33 clearances under this code; the FDA took a median of 227 days from receipt to decision on them.

4 were reviewed by an accredited third party.

What Do the Recalls Say?

The FDA has recorded 44 recalls under this product code since 2003. 1 was by a company in China. 11 are Class I, the most serious grade.

The root causes the FDA records most often are Component design/selection (9), Device Design (8) and Nonconforming Material/Component (8). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.