FDA product code SDS: Compression-Based Airway Clearance Device
SDS is the FDA product code for compression-based airway clearance device. It is a Class II device, regulated under 21 CFR 868.5665 and reviewed by the Anesthesiology panel. Devices under SDS reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
It is intended to support bronchial drainage breathing techniques by providing oscillating regional compression to the thorax.
Classification
| Field | Value |
|---|---|
| Device name | Compression-Based Airway Clearance Device |
| Device class | Class II |
| Regulation | 21 CFR 868.5665 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
Recalls for SDS devices
openFDA lists no recalls for product code SDS.
Frequently asked questions
What is FDA product code SDS?
SDS is the FDA product code for compression-based airway clearance device. It is a Class II device, regulated under 21 CFR 868.5665 and reviewed by the Anesthesiology panel.
What device class is SDS?
Class II, regulation 21 CFR 868.5665. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SDS
- Run a recall and safety report across every SDS manufacturer
- Watch product code SDS 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.