FDA product code BSA: Warmer, Blood, Electromagnetic Radiation
BSA is the FDA product code for warmer, blood, electromagnetic radiation. It is a Class III device, regulated under 21 CFR 864.9205 and reviewed by the Hematology panel. Devices under BSA reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Warmer, Blood, Electromagnetic Radiation |
| Device class | Class III |
| Regulation | 21 CFR 864.9205 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | PMA |
Recalls for BSA devices
openFDA lists no recalls for product code BSA.
Frequently asked questions
What is FDA product code BSA?
BSA is the FDA product code for warmer, blood, electromagnetic radiation. It is a Class III device, regulated under 21 CFR 864.9205 and reviewed by the Hematology panel.
What device class is BSA?
Class III, regulation 21 CFR 864.9205. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code BSA
- Run a recall and safety report across every BSA manufacturer
- Watch product code BSA 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.
All Hematology product codes · FDA product code lookup · 510(k) database search · 510(k) review times