System, Tomography, Computed, Emission

How Is KPS Classified?

System, Tomography, Computed, Emission is FDA product code KPS, Class 2, 21 CFR 892.1200.

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 21 clearances under this code; the FDA took a median of 88 days from receipt to decision on them.

2 went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Has Gone Wrong With It?

The FDA has recorded 443 recalls under this product code since 2002. 8 were by a company in China. 24 are Class I, the most serious grade.

The root causes the FDA records most often are Software design (94), Device Design (85) and Nonconforming Material/Component (73). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.