Ventilator, Continuous, Non-Life-Supporting

What Is FDA Product Code MNS?

Ventilator, Continuous, Non-Life-Supporting is FDA product code MNS, Class 2, 21 CFR 868.5895.

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 1 clearance under this code; the FDA took 433 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 21 recalls under this product code since 2007. 1 was by a company in China. 16 are Class I, the most serious grade.

The root causes the FDA records most often are Device Design (9), Process control (6) and Nonconforming Material/Component (2). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.