FDA product code OII: Arthrogram Tray

OII is the FDA product code for arthrogram tray. It is a Class II device, regulated under 21 CFR 892.1650 and reviewed by the Radiology panel. Devices under OII reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 9 recalls for OII devices, 9 initiated in the last five years.

Definition

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.

Classification

Recalls for OII devices

9 product recalls in 9 recall events; 9 initiated in the last five years and 9 still open. Most recent: 2026-02-27.

Frequently asked questions

What is FDA product code OII?

OII is the FDA product code for arthrogram tray. It is a Class II device, regulated under 21 CFR 892.1650 and reviewed by the Radiology panel.

What device class is OII?

Class II, regulation 21 CFR 892.1650. Typical premarket route: 510(k) exempt.

Have OII devices been recalled?

Yes: 9 product recalls across 9 recall events; the most recent began 2026-02-27.

Next steps

• Run an FDA pathway report with predicate devices for product code OII
• Run a recall and safety report across every OII manufacturer
• Watch product code OII for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

All Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times