OKL
- Product code
- OKL
- Device name
- Intravascular Administration Set, Automated Air Removal System
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5445
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- 510(k) clearances (all years, FDA)
- 2 (all years; only the last 3 years are listed here)
FDA classification definition
An intravascular administration set, automated air removal system is a prescription device used to detect and automatically remove air from an intravascular administration set with minimal to no interruption in the flow of the IV fluid.
Official FDA classification page: OKL
Classification and pathway per current FDA publications. Data from openFDA (CC0).