FDA product code OLF: Medevac Use Oxygen Generator
OLF is the FDA product code for medevac use oxygen generator. It is a Class II device, regulated under 21 CFR 868.5440 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under OLF. The average 510(k) review took 88 days (median 88).
Definition
A MEDEVAC oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve) to be used exclusively aboard a MEDEVAC helicopter and affixed to the helicopter. For general use portable oxygen generators, use product code CAW.
Classification
| Field | Value |
|---|---|
| Device name | Medevac Use Oxygen Generator |
| Device class | Class II |
| Regulation | 21 CFR 868.5440 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every OLF clearance
Top OLF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Carleton Life Support Systems, Inc. | 1 | 2008-12-22 |
Most recent OLF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K082829 | Carleton Life Support Systems, Inc. | AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS) | 2008-12-22 | 88 |
Recalls for OLF devices
openFDA lists no recalls for product code OLF.
Frequently asked questions
What is FDA product code OLF?
OLF is the FDA product code for medevac use oxygen generator. It is a Class II device, regulated under 21 CFR 868.5440 and reviewed by the Anesthesiology panel.
What device class is OLF?
Class II, regulation 21 CFR 868.5440. Typical premarket route: 510(k).
How long does a 510(k) take for product code OLF?
Across 1 cleared submissions the average was 88 days from receipt to decision (median 88).
Which companies have the most OLF clearances?
Carleton Life Support Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OLF
- Run a recall and safety report across every OLF manufacturer
- Watch product code OLF 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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