OKLClass II
Intravascular Administration Set, Automated Air Removal System
21 CFR 880.5445 / General Hospital
OKL is the FDA product code for Intravascular Administration Set, Automated Air Removal System, a class II device type, regulated under 21 CFR 880.5445. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OKL
- Device name
- Intravascular Administration Set, Automated Air Removal System
- FDA 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.
- Regulation
- 21 CFR 880.5445
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code OKL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2018 | 1 |
Applicants with the most clearances
Product code OKL| Applicant | Clearances |
|---|---|
| Anesthesia Safety Products, LLC | 1 |
| Clearline MD | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code OKL.
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