FDA product code OJH: Orthopedic Tray

OJH is the FDA product code for orthopedic tray. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the Orthopedic panel. Devices under OJH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 238 recalls for OJH devices, 153 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 www.fda.gov/cdrh/ode/convkit.html. 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 OJH devices

238 product recalls in 86 recall events; 153 initiated in the last five years and 136 still open. Most recent: 2026-08-10.

Frequently asked questions

What is FDA product code OJH?

OJH is the FDA product code for orthopedic tray. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the Orthopedic panel.

What device class is OJH?

Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.

Have OJH devices been recalled?

Yes: 238 product recalls across 86 recall events; the most recent began 2026-08-10.

Next steps

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