FDA product code OJG: Neurological Tray

OJG is the FDA product code for neurological tray. It is a Class I device, regulated under 21 CFR 882.4525 and reviewed by the Neurology panel. Devices under OJG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 92 recalls for OJG devices, 73 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 OJG devices

92 product recalls in 63 recall events; 73 initiated in the last five years and 57 still open. Most recent: 2026-08-10.

Frequently asked questions

What is FDA product code OJG?

OJG is the FDA product code for neurological tray. It is a Class I device, regulated under 21 CFR 882.4525 and reviewed by the Neurology panel.

What device class is OJG?

Class I, regulation 21 CFR 882.4525. Typical premarket route: 510(k) exempt.

Have OJG devices been recalled?

Yes: 92 product recalls across 63 recall events; the most recent began 2026-08-10.

Next steps

• Run an FDA pathway report with predicate devices for product code OJG
• Run a recall and safety report across every OJG manufacturer
• Watch product code OJG 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 Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times