OPP · Pump, Infusion, Insulin Bolus
General Hospital · 21 CFR 880.5725 · Class 2
Overview
| Product Code | OPP |
|---|---|
| Device Name | Pump, Infusion, Insulin Bolus |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
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 | CeQur Simplicity On-Demand Insulin Delivery System | Cequr SA | Apr 10, 2026 | SESE |
| K243273 | CeQur Simplicity On-Demand Insulin Delivery System | Cequr SA | Nov 13, 2024 | SESE |
| K233447 | CeQur Simplicity On-Demand Insulin Delivery System | Cequr SA | Jan 18, 2024 | SESE |
| K163357 | OneTouch Via On-Demand Insulin Delivery System | Lifescan Europe, A Division of Cilag GmbH | Jun 7, 2017 | SESE |
| K111924 | FINESSE PERSONAL INSULIN DELIVERY PATCH | Calibra Medical, Inc. | Apr 10, 2012 | SESE |
| K100947 | FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 | Calibra Medical, Inc. | Jun 28, 2010 | SESE |
| K093065 | 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
