# OZP · Automated Insulin Dosing Device System, Single Hormonal Control

_ ·  · Class 3_

**Canonical URL:** https://fda-staging.innolitics.com/productcode/OZP

## Overview

- **Product Code:** OZP
- **Device Name:** Automated Insulin Dosing Device System, Single Hormonal Control
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

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.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P160017S125](/device/P160017S125.md) | MiniMed 780G System | Medtronic Minimed, Inc. | Dec 11, 2025 | APPR |
| [P160017S124](/device/P160017S124.md) | MiniMed 780G System | Medtronic Minimed, Inc. | Aug 29, 2025 | APPR |
| [P160017S118](/device/P160017S118.md) | MiniMed 780G System | Medtronic Minimed, Inc. | Apr 18, 2025 | APPR |
| [P160017S091](/device/P160017S091.md) | MiniMed 780G System | Medtronic Minimed, Inc. | Apr 21, 2023 | APPR |
| [P160017S076](/device/P160017S076.md) | MiniMed 770G System | Medtronic Minimed, Inc. | Aug 31, 2020 | APPR |
| [P160017S031](/device/P160017S031.md) | MiniMed 670G System | Medtronic Minimed, Inc. | Jun 21, 2018 | APPR |
| [P160017S017](/device/P160017S017.md) | MiniMed 670G System | Medtronic Minimed, Inc. | Feb 13, 2018 | APPR |
| [P160017](/device/P160017.md) | MiniMed 670G System | Medtronic Minimed, Inc. | Sep 28, 2016 | APPR |

## Top Applicants

- Medtronic Minimed, Inc. — 8 clearances

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**Source:** [https://fda-staging.innolitics.com/productcode/OZP](https://fda-staging.innolitics.com/productcode/OZP)

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