FDA product code OKH: Body Fluids Barrier Kit
OKH is the FDA product code for body fluids barrier kit. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel. Devices under OKH 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 Fluids Barrier 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 OKH devices
openFDA lists no recalls for product code OKH.
Frequently asked questions
What is FDA product code OKH?
OKH is the FDA product code for body fluids barrier kit. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel.
What device class is OKH?
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 OKH
- Run a recall and safety report across every OKH manufacturer
- Watch product code OKH 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.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times