FDA product code LHE: Controller, Closed-Loop Blood Glucose
LHE is the FDA product code for controller, closed-loop blood glucose. It is a Class III device, reviewed by the Clinical Chemistry panel. Devices under LHE reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code.
Classification
| Field | Value |
|---|---|
| Device name | Controller, Closed-Loop Blood Glucose |
| Device class | Class III |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LHE devices
openFDA lists no recalls for product code LHE.
Frequently asked questions
What is FDA product code LHE?
LHE is the FDA product code for controller, closed-loop blood glucose. It is a Class III device, reviewed by the Clinical Chemistry panel.
What device class is LHE?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LHE
- Run a recall and safety report across every LHE manufacturer
- Watch product code LHE 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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