FDA product code OEZ: Cardiovascular Procedure Kit

OEZ is the FDA product code for cardiovascular procedure kit. It is a Class II device, regulated under 21 CFR 870.1200 and reviewed by the Cardiovascular panel. Devices under OEZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 226 recalls for OEZ devices, 149 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 OEZ devices

226 product recalls in 104 recall events; 149 initiated in the last five years and 144 still open. Most recent: 2026-08-11.

Frequently asked questions

What is FDA product code OEZ?

OEZ is the FDA product code for cardiovascular procedure kit. It is a Class II device, regulated under 21 CFR 870.1200 and reviewed by the Cardiovascular panel.

What device class is OEZ?

Class II, regulation 21 CFR 870.1200. Typical premarket route: 510(k) exempt.

Have OEZ devices been recalled?

Yes: 226 product recalls across 104 recall events; the most recent began 2026-08-11.

Next steps

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