Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5725](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5725) → OPP — Pump, Infusion, Insulin Bolus

# OPP · Pump, Infusion, Insulin Bolus

_General Hospital · 21 CFR 880.5725 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/OPP

## Overview

- **Product Code:** OPP
- **Device Name:** Pump, Infusion, Insulin Bolus
- **Regulation:** [21 CFR 880.5725](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5725)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K252757](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/OPP/K252757.md) | CeQur Simplicity™ On-Demand Insulin Delivery System | Cequr SA | Apr 10, 2026 | SESE |
| [K243273](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/OPP/K243273.md) | CeQur Simplicity™ On-Demand Insulin Delivery System | Cequr SA | Nov 13, 2024 | SESE |
| [K233447](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/OPP/K233447.md) | CeQur Simplicity™ On-Demand Insulin Delivery System | Cequr SA | Jan 18, 2024 | SESE |
| [K163357](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/OPP/K163357.md) | OneTouch Via On-Demand Insulin Delivery System | Lifescan Europe, A Division of Cilag GmbH | Jun 7, 2017 | SESE |
| [K111924](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/OPP/K111924.md) | FINESSE PERSONAL INSULIN DELIVERY PATCH | Calibra Medical, Inc. | Apr 10, 2012 | SESE |
| [K100947](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/OPP/K100947.md) | FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 | Calibra Medical, Inc. | Jun 28, 2010 | SESE |
| [K093065](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/OPP/K093065.md) | FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000 | Calibra Medical, Inc. | Jan 20, 2010 | SESE |

## Top Applicants

- Calibra Medical, Inc. — 3 clearances
- Cequr SA — 3 clearances
- Lifescan Europe, A Division of Cilag GmbH — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/OPP](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/OPP)

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