OPP
7 FDA 510(k) clearances · Product code
112 daysmedian time to decision
279 days90th percentile
7clearances measured
FDA profile
- Official device name
- Pump, Infusion, Insulin Bolus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Medical specialty
- General Hospital
- FDA definition
- The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.
- Adverse events (MAUDE)
- 2015: 22
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CeQur Simplicity™ On-Demand Insulin Delivery System (K252757) | Cequr SA | 2026-04-10 |
| CeQur Simplicity™ On-Demand Insulin Delivery System (K243273) | Cequr SA | 2024-11-13 |
| CeQur Simplicity™ On-Demand Insulin Delivery System (K233447) | Cequr SA | 2024-01-18 |
| OneTouch Via On-Demand Insulin Delivery System (K163357) | Lifescan Europe, A Division of Cilag GmbH | 2017-06-07 |
| FINESSE PERSONAL INSULIN DELIVERY PATCH (K111924) | Calibra Medical, Inc. | 2012-04-10 |
| FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 (K100947) | Calibra Medical, Inc. | 2010-06-28 |
| FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000 (K093065) | Calibra Medical, Inc. | 2010-01-20 |
Track OPP automatically
Every clearance here is in the API, with alerts when new ones post.