FDA product code SFI: Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System
SFI is the FDA product code for sensor, glucose, invasive, component of automated insulin delivery system. It is a Class III device, reviewed by the Clinical Chemistry panel. Devices under SFI reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
The device is intended to measure glucose in interstitial fluid. It is intended to provide those measurements as inputs to appropriately qualified digitally connected devices, including automated insulin dosing systems, as determined by FDA.
Classification
| Field | Value |
|---|---|
| Device name | Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System |
| Device class | Class III |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for SFI devices
openFDA lists no recalls for product code SFI.
Frequently asked questions
What is FDA product code SFI?
SFI is the FDA product code for sensor, glucose, invasive, component of automated insulin delivery system. It is a Class III device, reviewed by the Clinical Chemistry panel.
What device class is SFI?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code SFI
- Run a recall and safety report across every SFI manufacturer
- Watch product code SFI 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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