Heater, Breathing System W/Wo Controller (Not Humidifier or Nebulizer

What Is FDA Product Code BZE?

Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer is FDA product code BZE, Class 2, 21 CFR 868.5270.

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 1 clearance under this code; the FDA took 287 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 7 recalls under this product code since 2012. None was by a company in China. 6 are Class I, the most serious grade.

The root causes the FDA records most often are Equipment maintenance (3), Component design/selection (2) and Process control (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.