FDA product code BSI: Algesimeter, Powered
BSI is the FDA product code for algesimeter, powered. It is a Class II device, regulated under 21 CFR 868.1040 and reviewed by the Anesthesiology panel. Devices under BSI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Algesimeter, Powered |
| Device class | Class II |
| Regulation | 21 CFR 868.1040 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Recalls for BSI devices
openFDA lists no recalls for product code BSI.
Frequently asked questions
What is FDA product code BSI?
BSI is the FDA product code for algesimeter, powered. It is a Class II device, regulated under 21 CFR 868.1040 and reviewed by the Anesthesiology panel.
What device class is BSI?
Class II, regulation 21 CFR 868.1040. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code BSI
- Run a recall and safety report across every BSI manufacturer
- Watch product code BSI 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.