FDA product code OZP: Automated Insulin Dosing Device System, Single Hormonal Control

OZP is the FDA product code for automated insulin dosing device system, single hormonal control. It is a Class III device, reviewed by the Clinical Chemistry panel. Devices under OZP reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 23 recalls for OZP devices, 15 initiated in the last five years.

Definition

An insulin-only automated insulin dosing system that achieves a target glucose level by automatically increasing or reducing insulin infusion from an insulin pump. Insulin adjustments are based upon specified thresholds of measured glucose levels.

Classification

Recalls for OZP devices

23 product recalls in 13 recall events; 15 initiated in the last five years and 21 still open. Most recent: 2026-07-13.

Frequently asked questions

What is FDA product code OZP?

OZP is the FDA product code for automated insulin dosing device system, single hormonal control. It is a Class III device, reviewed by the Clinical Chemistry panel.

What device class is OZP?

Class III. Typical premarket route: PMA.

Have OZP devices been recalled?

Yes: 23 product recalls across 13 recall events; the most recent began 2026-07-13.

Next steps

• Run an FDA pathway report with predicate devices for product code OZP
• Run a recall and safety report across every OZP manufacturer
• Watch product code OZP 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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