Apparatus, Suction, Ward Use, Portable, Ac-Powered

How Is JCX Classified?

Apparatus, Suction, Ward Use, Portable, Ac-Powered is FDA product code JCX, Class 2, 21 CFR 878.4780.

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 3 clearances under this code; the FDA took a median of 204 days from receipt to decision on them.

2 were reviewed by an accredited third party.

What Has Gone Wrong With It?

The FDA has recorded 24 recalls under this product code since 2004. 1 was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (8), Device Design (4) and Component design/selection (3).

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