Intravascular Administration Set, Automated Air Removal System
The Intravascular Administration Set, Automated Air Removal System (product code OKL) is a prescription Class 2 device regulated under 21 CFR 880.5445 in the General Hospital specialty (HO), cleared via 510(k). It is intended to detect and automatically remove air from an intravascular administration set with minimal to no interruption in IV fluid flow, reducing the risk of air embolism during intravenous therapy. The device is not an implant and is not classified as life-sustaining or life-supporting.
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Basic Information
- Product Code
- OKL
- Device Class
- FDA class 2
- Regulation Number
- 880.5445
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.