FDA product code OKI: Emergency Response Safety Kit

OKI is the FDA product code for emergency response safety kit. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel. Devices under OKI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 5 recalls for OKI devices, 5 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 OKI devices

5 product recalls in 2 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2025-12-15.

Frequently asked questions

What is FDA product code OKI?

OKI is the FDA product code for emergency response safety kit. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel.

What device class is OKI?

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

Have OKI devices been recalled?

Yes: 5 product recalls across 2 recall events; the most recent began 2025-12-15.

Next steps

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