FDA product code OFS: Tracheal Suction Set
OFS is the FDA product code for tracheal suction set. It is a Class I device, regulated under 21 CFR 868.6810 and reviewed by the Anesthesiology panel. Devices under OFS 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 | Tracheal Suction Set |
| Device class | Class I |
| Regulation | 21 CFR 868.6810 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Recalls for OFS devices
openFDA lists no recalls for product code OFS.
Frequently asked questions
What is FDA product code OFS?
OFS is the FDA product code for tracheal suction set. It is a Class I device, regulated under 21 CFR 868.6810 and reviewed by the Anesthesiology panel.
What device class is OFS?
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 OFS
- Run a recall and safety report across every OFS manufacturer
- Watch product code OFS 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.