OPP — Pump, Infusion, Insulin Bolus Class II
Classification Details
- Product Code
- OPP
- Device Class
- Class II
- Regulation Number
- 880.5725
- Submission Type
- Review Panel
- CH
- Medical Specialty
- General Hospital
- Implant
- No
Definition
The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252757 | cequr | CeQur Simplicity On-Demand Insulin Delivery System | April 10, 2026 |
| K243273 | cequr | CeQur Simplicity On-Demand Insulin Delivery System | November 13, 2024 |
| K233447 | cequr | CeQur Simplicity On-Demand Insulin Delivery System | January 18, 2024 |
| K163357 | lifescan europe, a division of cilag | OneTouch Via On-Demand Insulin Delivery System | June 7, 2017 |
| K111924 | calibra medical | FINESSE PERSONAL INSULIN DELIVERY PATCH | April 10, 2012 |
| K100947 | calibra medical | FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 | June 28, 2010 |
| K093065 | calibra medical | FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000 | January 20, 2010 |