Enteral Specific Transition Connectors

What Is It?

Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.

How Is PIO Classified?

Enteral Specific Transition Connectors is FDA product code PIO, 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 1 clearance under this code; the FDA took 112 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 3 recalls under this product code since 2020. None was by a company in China. The root causes the FDA records most often are Process change control (2) and Labeling Change Control (1).

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