System, X-Ray, Stationary

How Is KPR Classified?

System, X-Ray, Stationary is FDA product code KPR, Class 2, 21 CFR 892.1680.

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 24 clearances under this code; the FDA took a median of 30 days from receipt to decision on them.

10 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 Do the Recalls Say?

The FDA has recorded 168 recalls under this product code since 2003. 7 were by a company in China. The root causes the FDA records most often are Device Design (36), Software design (28) and Radiation Control for Health and Safety Act (23).

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