Emergency Response Safety Kit
The Emergency Response Safety Kit (product code OKI) is a convenience kit assembled for emergency response situations, falling under General, Plastic Surgery (medical specialty SU) and regulated under 21 CFR 878.4040. As a Class 2 device, it would normally require 510(k) clearance, but per the FDA's May 20, 1997 Convenience Kits Interim Regulatory Guidance, kits of this type are under enforcement discretion and do not require a premarket notification if all specified criteria are met. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OKI
- Device Class
- FDA class 2
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 7
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.