Probe, Blood-Flow, Extravascular

What Is FDA Product Code DPT?

Probe, Blood-Flow, Extravascular is FDA product code DPT, Class 2, 21 CFR 870.2120.

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. 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 245 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 24 recalls under this product code since 2005. None was by a company in China. The root cause the FDA records most often is Process control (23).

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