FDA product code OFO: Airway Suction Kit
OFO is the FDA product code for airway suction kit. It is a Class I device, regulated under 21 CFR 868.6810 and reviewed by the Anesthesiology panel. Devices under OFO reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
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 type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Airway Suction Kit |
| Device class | Class I |
| Regulation | 21 CFR 868.6810 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Recalls for OFO devices
openFDA lists no recalls for product code OFO.
Frequently asked questions
What is FDA product code OFO?
OFO is the FDA product code for airway suction kit. It is a Class I device, regulated under 21 CFR 868.6810 and reviewed by the Anesthesiology panel.
What device class is OFO?
Class I, regulation 21 CFR 868.6810. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OFO
- Run a recall and safety report across every OFO manufacturer
- Watch product code OFO 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.