Pump, Infusion, Insulin Bolus
The Pump, Infusion, Insulin Bolus (product code OPP) is a Class 2 General Hospital device regulated under 21 CFR 880.5725, cleared via 510(k) and reviewed by the Clinical Chemistry panel. It is adhered to the body for several days and is designed to periodically infuse a bolus of insulin, functioning as a patch-style insulin delivery system for diabetes management. The device is not an implant and is not life-sustaining.
Basic Information
- Product Code
- OPP
- Device Class
- FDA class 2
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
Definition
The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243273 | CeQur Simplicity On-Demand Insulin Delivery System | Nov 13, 2024 | Substantially Equivalent | CeQur SA |
| K233447 | CeQur Simplicity On-Demand Insulin Delivery System | Jan 18, 2024 | Substantially Equivalent | CeQur SA |
| K163357 | OneTouch Via On-Demand Insulin Delivery System | Jun 07, 2017 | Substantially Equivalent | LifeScan Europe, a division of Cilag GmbH |
| K111924 | FINESSE PERSONAL INSULIN DELIVERY PATCH | Apr 10, 2012 | Substantially Equivalent | CALIBRA MEDICAL, INC. |
| K100947 | FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 | Jun 28, 2010 | Substantially Equivalent | CALIBRA MEDICAL, INC. |
| K093065 | FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000 | Jan 20, 2010 | Substantially Equivalent | CALIBRA MEDICAL, INC. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.