FDA product code OJK: Eye Tray

OJK is the FDA product code for eye tray. It is a Class II device, regulated under 21 CFR 886.4790 and reviewed by the Ophthalmic panel. Devices under OJK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 73 recalls for OJK devices, 52 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 OJK devices

73 product recalls in 46 recall events; 52 initiated in the last five years and 46 still open. Most recent: 2026-07-31.

Frequently asked questions

What is FDA product code OJK?

OJK is the FDA product code for eye tray. It is a Class II device, regulated under 21 CFR 886.4790 and reviewed by the Ophthalmic panel.

What device class is OJK?

Class II, regulation 21 CFR 886.4790. Typical premarket route: 510(k) exempt.

Have OJK devices been recalled?

Yes: 73 product recalls across 46 recall events; the most recent began 2026-07-31.

Next steps

• Run an FDA pathway report with predicate devices for product code OJK
• Run a recall and safety report across every OJK manufacturer
• Watch product code OJK 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.

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