OPP — Pump, Infusion, Insulin Bolus Class II
FDA product code OPP covers "Pump, Infusion, Insulin Bolus", a Class II medical device regulated under 21 CFR 880.5725. Submissions are reviewed by the General Hospital panel. At least 7 recent 510(k) clearances have been granted under this product code.
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 | Apr 10, 2026 |
| K243273 | Cequr | CeQur Simplicity On-Demand Insulin Delivery System | Nov 13, 2024 |
| K233447 | Cequr | CeQur Simplicity On-Demand Insulin Delivery System | Jan 18, 2024 |
| K163357 | Lifescan Europe, A Division Of Cilag | OneTouch Via On-Demand Insulin Delivery System | Jun 7, 2017 |
| K111924 | Calibra Medical | FINESSE PERSONAL INSULIN DELIVERY PATCH | Apr 10, 2012 |
| K100947 | Calibra Medical | FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 | Jun 28, 2010 |
| K093065 | Calibra Medical | FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000 | Jan 20, 2010 |