Percussor, Powered-Electric

What Is FDA Product Code BYI?

Percussor, Powered-Electric is FDA product code BYI, Class 2, 21 CFR 868.5665.

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 254 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 3 recalls under this product code since 2014. None was by a company in China. The root cause the FDA records most often is Process control (2).

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