Midline Catheter

What Is It?

The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days.

How Is PND Classified?

Midline Catheter is FDA product code PND, Class 2, 21 CFR 880.5200.

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. Chinese applicants hold 1 clearance under this code; the FDA took 140 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 10 recalls under this product code since 2019. None was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Nonconforming Material/Component (6), Packaging process control (1) and Process control (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.