FDA product code SBE: Digital Physical/Chemical Sterilization Process Sensor
SBE is the FDA product code for digital physical/chemical sterilization process sensor. It is a Class II device, regulated under 21 CFR 880.2801 and reviewed by the General Hospital panel. Devices under SBE reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
A digital physical/chemical sterilization process sensor is a device intended to monitor one or more parameter(s) of the sterilization process. The adequacy of the sterilization conditions as measured by the parameter(s) is/are indicated by a digital readout of the result.
Classification
| Field | Value |
|---|---|
| Device name | Digital Physical/Chemical Sterilization Process Sensor |
| Device class | Class II |
| Regulation | 21 CFR 880.2801 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Recalls for SBE devices
openFDA lists no recalls for product code SBE.
Frequently asked questions
What is FDA product code SBE?
SBE is the FDA product code for digital physical/chemical sterilization process sensor. It is a Class II device, regulated under 21 CFR 880.2801 and reviewed by the General Hospital panel.
What device class is SBE?
Class II, regulation 21 CFR 880.2801. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SBE
- Run a recall and safety report across every SBE manufacturer
- Watch product code SBE 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.
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