Tube, Feeding

How Is FPD Classified?

Tube, Feeding is FDA product code FPD, Class 2, 21 CFR 876.5980.

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. Chinese applicants hold 2 clearances under this code; the FDA took a median of 200 days from receipt to decision on them. 1 was reviewed by an accredited third party.

What Do the Recalls Say?

The FDA has recorded 24 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Process control (4), Finished device change control (4) and Nonconforming Material/Component (1).

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