Unit, Neonatal Phototherapy

What Is FDA Product Code LBI?

Unit, Neonatal Phototherapy is FDA product code LBI, Class 2, 21 CFR 880.5700.

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 272 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 14 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Device Design (5), Labeling False and Misleading (1) and No Marketing Application (1).

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