FDA product code OGL: Oxygen Administration Kit
OGL is the FDA product code for oxygen administration kit. It is a Class II device, regulated under 21 CFR 868.5655 and reviewed by the Anesthesiology panel. Devices under OGL reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for OGL devices.
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Classification
| Field | Value |
|---|---|
| Device name | Oxygen Administration Kit |
| Device class | Class II |
| Regulation | 21 CFR 868.5655 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Recalls for OGL devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-10-17.
Frequently asked questions
What is FDA product code OGL?
OGL is the FDA product code for oxygen administration kit. It is a Class II device, regulated under 21 CFR 868.5655 and reviewed by the Anesthesiology panel.
What device class is OGL?
Class II, regulation 21 CFR 868.5655. Typical premarket route: 510(k) exempt.
Have OGL devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2011-10-17.
Next steps
- Run an FDA pathway report with predicate devices for product code OGL
- Run a recall and safety report across every OGL manufacturer
- Watch product code OGL 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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