Calculator, Predicted Values, Pulmonary Function

What Is FDA Product Code BTY?

Calculator, Predicted Values, Pulmonary Function is FDA product code BTY, Class 2, 21 CFR 868.1890.

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 1 clearance under this code; the FDA took 266 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 4 recalls under this product code since 2014. None was by a company in China. The root cause the FDA records most often is Component change control (2).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.