FDA product code OKV: Obstetrical Kit

OKV is the FDA product code for obstetrical kit. It is a Class II device, regulated under 21 CFR 884.4520 and reviewed by the Obstetrics and Gynecology panel. Devices under OKV reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 91 recalls for OKV devices, 37 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 OKV devices

91 product recalls in 30 recall events; 37 initiated in the last five years and 37 still open. Most recent: 2026-07-10.

Frequently asked questions

What is FDA product code OKV?

OKV is the FDA product code for obstetrical kit. It is a Class II device, regulated under 21 CFR 884.4520 and reviewed by the Obstetrics and Gynecology panel.

What device class is OKV?

Class II, regulation 21 CFR 884.4520. Typical premarket route: 510(k) exempt.

Have OKV devices been recalled?

Yes: 91 product recalls across 30 recall events; the most recent began 2026-07-10.

Next steps

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