Gas-Machine, Anesthesia

What Is FDA Product Code BSZ?

Gas-Machine, Anesthesia is FDA product code BSZ, Class 2, 21 CFR 868.5160.

What Does It Take to Sell It in the United States?

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. Chinese applicants hold 6 clearances under this code; the FDA took a median of 255 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 177 recalls under this product code since 2003. 23 were by a company in China. 67 are Class I, the most serious grade.

The root causes the FDA records most often are Device Design (45), Process control (26) and Nonconforming Material/Component (24). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.