Speculum, Vaginal, Metal

How Is HDF Classified?

Speculum, Vaginal, Metal is FDA product code HDF, Class 1, 21 CFR 884.4520.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 3 recalls under this product code since 2019. None was by a company in China. The root causes the FDA records most often are Labeling mix-ups (1) and Employee error (1).

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