Enteral Syringes With Enteral Specific Connectors

What Is It?

Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.

What Is FDA Product Code PNR?

Enteral Syringes With Enteral Specific Connectors is FDA product code PNR, 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 14 clearances under this code; the FDA took a median of 183 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 4 recalls under this product code since 2023. None was by a company in China. 4 are Class I, the most serious grade.

The root cause the FDA records most often is Process change control (4). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.