FDA product code CAG: Circulator, Breathing-Circuit
CAG is the FDA product code for circulator, breathing-circuit. It is a Class II device, regulated under 21 CFR 868.5250 and reviewed by the Anesthesiology panel. Devices under CAG reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Circulator, Breathing-Circuit |
| Device class | Class II |
| Regulation | 21 CFR 868.5250 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Recalls for CAG devices
openFDA lists no recalls for product code CAG.
Frequently asked questions
What is FDA product code CAG?
CAG is the FDA product code for circulator, breathing-circuit. It is a Class II device, regulated under 21 CFR 868.5250 and reviewed by the Anesthesiology panel.
What device class is CAG?
Class II, regulation 21 CFR 868.5250. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code CAG
- Run a recall and safety report across every CAG manufacturer
- Watch product code CAG 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.