What Is This Device?
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
How Is OII Classified?
Arthrogram Tray is FDA product code OII, Class 2, 21 CFR 892.1650.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
What Do the Recalls Say?
The FDA has recorded 9 recalls under this product code since 2022. None was by a company in China. The root causes the FDA records most often are Device Design (2), No Marketing Application (1) and Process control (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.