FDA product code OJR: Vacuum Powered Body Fluid Collection Kit

OJR is the FDA product code for vacuum powered body fluid collection kit. It is a Class II device, regulated under 21 CFR 878.4780 and reviewed by the General and Plastic Surgery panel. Devices under OJR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for OJR 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 OJR devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-02-10.

Frequently asked questions

What is FDA product code OJR?

OJR is the FDA product code for vacuum powered body fluid collection kit. It is a Class II device, regulated under 21 CFR 878.4780 and reviewed by the General and Plastic Surgery panel.

What device class is OJR?

Class II, regulation 21 CFR 878.4780. Typical premarket route: 510(k) exempt.

Have OJR devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2014-02-10.

Next steps

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