FDA product code OKU: Emergency Obstetrical Kit
OKU is the FDA product code for emergency obstetrical kit. It is a Class I device, regulated under 21 CFR 884.4520 and reviewed by the Obstetrics and Gynecology panel. Devices under OKU reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
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
| Field | Value |
|---|---|
| Device name | Emergency Obstetrical Kit |
| Device class | Class I |
| Regulation | 21 CFR 884.4520 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for OKU devices
openFDA lists no recalls for product code OKU.
Frequently asked questions
What is FDA product code OKU?
OKU is the FDA product code for emergency obstetrical kit. It is a Class I device, regulated under 21 CFR 884.4520 and reviewed by the Obstetrics and Gynecology panel.
What device class is OKU?
Class I, regulation 21 CFR 884.4520. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OKU
- Run a recall and safety report across every OKU manufacturer
- Watch product code OKU 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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