FDA product code OKW: Seminal Fluid Collection Kit
OKW is the FDA product code for seminal fluid collection kit. It is a Class II device, regulated under 21 CFR 884.5300 and reviewed by the Obstetrics and Gynecology panel. Devices under OKW 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 | Seminal Fluid Collection Kit |
| Device class | Class II |
| Regulation | 21 CFR 884.5300 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for OKW devices
openFDA lists no recalls for product code OKW.
Frequently asked questions
What is FDA product code OKW?
OKW is the FDA product code for seminal fluid collection kit. It is a Class II device, regulated under 21 CFR 884.5300 and reviewed by the Obstetrics and Gynecology panel.
What device class is OKW?
Class II, regulation 21 CFR 884.5300. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OKW
- Run a recall and safety report across every OKW manufacturer
- Watch product code OKW 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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