# PQF · Sensor, Glucose, Invasive, Non-Adjunctive

_ ·  · Class 3_

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

## Overview

- **Product Code:** PQF
- **Device Name:** Sensor, Glucose, Invasive, Non-Adjunctive
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P160007S047](/device/P160007S047.md) | Simplera™ System | Medtronic Minimed | Jul 24, 2024 | APPR |
| [P120005S041](/device/P120005S041.md) | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | Dexcom, Inc. | Dec 20, 2016 | APPR |

## Top Applicants

- Dexcom, Inc. — 1 clearance
- Medtronic Minimed — 1 clearance

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

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