FDA product code OJV: Single Use Instrument Tray

OJV is the FDA product code for single use instrument tray. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. Devices under OJV reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 38 recalls for OJV devices.

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 OJV devices

38 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-09-20.

Frequently asked questions

What is FDA product code OJV?

OJV is the FDA product code for single use instrument tray. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.

What device class is OJV?

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

Have OJV devices been recalled?

Yes: 38 product recalls across 3 recall events; the most recent began 2017-09-20.

Next steps

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