FDA product code OKG: Body Fluid Clean Up Kit

OKG is the FDA product code for body fluid clean up kit. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel. Devices under OKG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 3 recalls for OKG devices, 3 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 OKG devices

3 product recalls in 3 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2024-06-27.

Frequently asked questions

What is FDA product code OKG?

OKG is the FDA product code for body fluid clean up kit. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel.

What device class is OKG?

Class II, regulation 21 CFR 878.4040. Typical premarket route: 510(k) exempt.

Have OKG devices been recalled?

Yes: 3 product recalls across 3 recall events; the most recent began 2024-06-27.

Next steps

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