Catheter, Retention Type, Balloon

How Is EZL Classified?

Catheter, Retention Type, Balloon is FDA product code EZL, Class 2, 21 CFR 876.5130.

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 8 clearances under this code; the FDA took a median of 255 days from receipt to decision on them.

One went the Special 510(k) route, the one for a change to the applicant’s own cleared device. 1 was reviewed by an accredited third party.

What Has Gone Wrong With It?

The FDA has recorded 85 recalls under this product code since 2016. None was by a company in China. 2 are Class I, the most serious grade.

The root causes the FDA records most often are Nonconforming Material/Component (38), Employee error (32) and Packaging change control (4). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.