DeviceClearance

Product code OKL— General Hospital

AIRPURGE

Classification name
Intravascular Administration Set, Automated Air Removal System
Device class
Class 2
Regulation
21 CFR 880.5445
Advisory panel
General Hospital
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OKL under 21 CFR 880.5445, via openFDA

Market context for product code OKL

FDA has cleared 2 devices under product code OKL between 2014 and 2018, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OKL

Recent clearances under product code OKL

Data sourced from openFDA. This site is unofficial and independent of the FDA.