FDA product code NMA: Tube, Tracheal, Reprocessed
NMA is the FDA product code for tube, tracheal, reprocessed. It is a Class II device, regulated under 21 CFR 868.5730 and reviewed by the Anesthesiology panel. Devices under NMA reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Tube, Tracheal, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 868.5730 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Recalls for NMA devices
openFDA lists no recalls for product code NMA.
Frequently asked questions
What is FDA product code NMA?
NMA is the FDA product code for tube, tracheal, reprocessed. It is a Class II device, regulated under 21 CFR 868.5730 and reviewed by the Anesthesiology panel.
What device class is NMA?
Class II, regulation 21 CFR 868.5730. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NMA
- Run a recall and safety report across every NMA manufacturer
- Watch product code NMA 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.