Humidifier Nebulizer Kit

What Is It?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

How Is OGG Classified?

Humidifier Nebulizer Kit is FDA product code OGG, Class 2, 21 CFR 868.5450.

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

The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.

What Do the Recalls Say?

The FDA has recorded 2 recalls under this product code since 2014. None was by a company in China. The root cause the FDA records most often is Packaging change control (1).

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