Ventilator, Emergency, Manual (Resuscitator)

What Is FDA Product Code BTM?

Ventilator, Emergency, Manual (Resuscitator) is FDA product code BTM, Class 2, 21 CFR 868.5915.

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 4 clearances under this code; the FDA took a median of 171 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 97 recalls under this product code since 2002. 1 was by a company in China. 30 are Class I, the most serious grade.

The root causes the FDA records most often are Device Design (32), Mixed-up of materials/components (14) and Component design/selection (13). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.