FDA product code PKU: Insulin Pump Secondary Display
PKU is the FDA product code for insulin pump secondary display. It is a Class II device, regulated under 21 CFR 862.1350 and reviewed by the Clinical Chemistry panel. Devices under PKU reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. The secondary display is intended for providing secondary notification of insulin pump usage and does not replace primary real time insulin pump monitoring or standard home blood glucose monitoring.
Classification
| Field | Value |
|---|---|
| Device name | Insulin Pump Secondary Display |
| Device class | Class II |
| Regulation | 21 CFR 862.1350 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for PKU devices
openFDA lists no recalls for product code PKU.
Frequently asked questions
What is FDA product code PKU?
PKU is the FDA product code for insulin pump secondary display. It is a Class II device, regulated under 21 CFR 862.1350 and reviewed by the Clinical Chemistry panel.
What device class is PKU?
Class II, regulation 21 CFR 862.1350. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PKU
- Run a recall and safety report across every PKU manufacturer
- Watch product code PKU 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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