FDA product code OKF: Body Fluid Disposal Kit
OKF is the FDA product code for body fluid disposal kit. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel. Devices under OKF 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 | Body Fluid Disposal Kit |
| Device class | Class II |
| Regulation | 21 CFR 878.4040 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for OKF devices
openFDA lists no recalls for product code OKF.
Frequently asked questions
What is FDA product code OKF?
OKF is the FDA product code for body fluid disposal kit. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel.
What device class is OKF?
Class II, regulation 21 CFR 878.4040. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OKF
- Run a recall and safety report across every OKF manufacturer
- Watch product code OKF 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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