FDA product code OKL: Intravascular Administration Set, Automated Air Removal System
OKL is the FDA product code for intravascular administration set, automated air removal system. It is a Class II device, regulated under 21 CFR 880.5445 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under OKL. The average 510(k) review took 210 days (median 210). 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Intravascular Administration Set, Automated Air Removal System |
| Device class | Class II |
| Regulation | 21 CFR 880.5445 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for OKL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 210 |
Compare with all 510(k) review times · Search every OKL clearance
Top OKL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Clearline MD | 1 | 2018-01-25 |
Most recent OKL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K171954 | Clearline MD | ClearLine IV | 2018-01-25 | 210 |
Recalls for OKL devices
openFDA lists no recalls for product code OKL.
Frequently asked questions
What is FDA product code OKL?
OKL is the FDA product code for intravascular administration set, automated air removal system. It is a Class II device, regulated under 21 CFR 880.5445 and reviewed by the General Hospital panel.
What device class is OKL?
Class II, regulation 21 CFR 880.5445. Typical premarket route: 510(k).
How long does a 510(k) take for product code OKL?
Across 1 cleared submissions the average was 210 days from receipt to decision (median 210).
Which companies have the most OKL clearances?
Clearline MD (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OKL
- Run a recall and safety report across every OKL manufacturer
- Watch product code OKL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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