FDA product code OEV: Cardiopulmonary Resuscitation Aid Kit

OEV is the FDA product code for cardiopulmonary resuscitation aid kit. It is a Class II device, regulated under 21 CFR 868.5915 and reviewed by the Anesthesiology panel. Devices under OEV reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 36 recalls for OEV 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 OEV devices

36 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-05-19.

Frequently asked questions

What is FDA product code OEV?

OEV is the FDA product code for cardiopulmonary resuscitation aid kit. It is a Class II device, regulated under 21 CFR 868.5915 and reviewed by the Anesthesiology panel.

What device class is OEV?

Class II, regulation 21 CFR 868.5915. Typical premarket route: 510(k) exempt.

Have OEV devices been recalled?

Yes: 36 product recalls across 2 recall events; the most recent began 2020-05-19.

Next steps

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