FDA product code OZO: Automated Insulin Dosing , Threshold Suspend
OZO is the FDA product code for automated insulin dosing , threshold suspend. It is a Class III device, reviewed by the Clinical Chemistry panel. Devices under OZO reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code. FDA has posted 11 recalls for OZO devices, 5 initiated in the last five years.
Definition
An automated insulin dosing system that temporarily suspends or reduces insulin infusion from an insulin pump based upon specified thresholds of measured glucose levels.
Classification
| Field | Value |
|---|---|
| Device name | Automated Insulin Dosing , Threshold Suspend |
| Device class | Class III |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for OZO devices
11 product recalls in 9 recall events; 5 initiated in the last five years and 8 still open. Most recent: 2026-02-13.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code OZO?
OZO is the FDA product code for automated insulin dosing , threshold suspend. It is a Class III device, reviewed by the Clinical Chemistry panel.
What device class is OZO?
Class III. Typical premarket route: PMA.
Have OZO devices been recalled?
Yes: 11 product recalls across 9 recall events; the most recent began 2026-02-13.
Next steps
- Run an FDA pathway report with predicate devices for product code OZO
- Run a recall and safety report across every OZO manufacturer
- Watch product code OZO 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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