FDA product code OJJ: Burn Kit Without Drug

OJJ is the FDA product code for burn kit without drug. It is a Class I device, regulated under 21 CFR 878.4022 and reviewed by the General and Plastic Surgery panel. Devices under OJJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 7 recalls for OJJ devices, 6 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 OJJ devices

7 product recalls in 7 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2026-01-07.

Frequently asked questions

What is FDA product code OJJ?

OJJ is the FDA product code for burn kit without drug. It is a Class I device, regulated under 21 CFR 878.4022 and reviewed by the General and Plastic Surgery panel.

What device class is OJJ?

Class I, regulation 21 CFR 878.4022. Typical premarket route: 510(k) exempt.

Have OJJ devices been recalled?

Yes: 7 product recalls across 7 recall events; the most recent began 2026-01-07.

Next steps

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